Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-04 @ 6:56 AM
Study NCT ID:
NCT00466960
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001948', 'term': 'Brenner Tumor'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D018225', 'term': 'Neoplasms, Fibroepithelial'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}, {'id': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bgoff@u.washington.edu', 'phone': '206-543-3668', 'title': 'Barbara Goff', 'organization': 'Seattle Cancer Care Alliance'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies', 'otherNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Allergic Reaction/Hypersensitivity (Including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Immune system disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Low HCT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hematocrit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'RBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Rigors/Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Death not associated with CTCAE term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hair loss/alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Injection site reaction/extravasation changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Nail Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash: Acne/Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mucositis/stomatitis (functional/symptomatic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Edema:limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'GFR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Low Protein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Arthralgia (Pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Head pain/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Joint Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Muscle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Myalgia (Pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Urinary Retention (including neurogenic bladder)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Obstruction, GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'groupId': 'OG000', 'lowerLimit': '2.74', 'upperLimit': '6.71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Median time to progression', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Number of patients achieving a complete or partial response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between Circulating Monocytes and Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '20.75', 'groupId': 'OG000', 'lowerLimit': '10.98', 'upperLimit': '24.93'}]}]}, {'title': 'PR+NR+SD', 'categories': [{'measurements': [{'value': '12.75', 'groupId': 'OG000', 'lowerLimit': '11.24', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).', 'unitOfMeasure': 'percentage of CD45+ in PBSC', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'title': 'mDC in CR', 'categories': [{'measurements': [{'value': '1.543', 'groupId': 'OG000', 'lowerLimit': '1.075', 'upperLimit': '3.504'}]}]}, {'title': 'mDC in PR+NR+SD', 'categories': [{'measurements': [{'value': '1.996', 'groupId': 'OG000', 'lowerLimit': '1.232', 'upperLimit': '2.42'}]}]}, {'title': 'pDC in CR', 'categories': [{'measurements': [{'value': '0.2465', 'groupId': 'OG000', 'lowerLimit': '0.1924', 'upperLimit': '0.3362'}]}]}, {'title': 'pDC in PR+NR+SD', 'categories': [{'measurements': [{'value': '0.3743', 'groupId': 'OG000', 'lowerLimit': '0.2311', 'upperLimit': '0.5067'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).', 'unitOfMeasure': '% of CD45+PBMC', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'title': 'IGF1R-p1196-1210', 'categories': [{'measurements': [{'value': '0.5056', 'groupId': 'OG000', 'lowerLimit': '-0.03429', 'upperLimit': '0.8171'}]}]}, {'title': 'IGF1R-p1242-1256', 'categories': [{'measurements': [{'value': '0.8496', 'groupId': 'OG000', 'lowerLimit': '0.5807', 'upperLimit': '0.9513'}]}]}, {'title': 'IGF1R-p1332-1346', 'categories': [{'measurements': [{'value': '0.8269', 'groupId': 'OG000', 'lowerLimit': '0.5279', 'upperLimit': '0.9435'}]}]}, {'title': 'IGFBP2', 'categories': [{'measurements': [{'value': '0.3676', 'groupId': 'OG000', 'lowerLimit': '-0.2982', 'upperLimit': '0.7927'}]}]}, {'title': 'p53', 'categories': [{'measurements': [{'value': '-0.02268', 'groupId': 'OG000', 'lowerLimit': '-0.5667', 'upperLimit': '0.5351'}]}]}, {'title': 'PRAME', 'categories': [{'measurements': [{'value': '-0.0817', 'groupId': 'OG000', 'lowerLimit': '-0.5869', 'upperLimit': '0.4693'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.', 'unitOfMeasure': 'Pearson correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'classes': [{'title': 'PHA', 'categories': [{'measurements': [{'value': '-0.08759', 'groupId': 'OG000', 'lowerLimit': '-0.5908', 'upperLimit': '0.4647'}]}]}, {'title': 'CEF', 'categories': [{'measurements': [{'value': '-0.1818', 'groupId': 'OG000', 'lowerLimit': '-0.6498', 'upperLimit': '0.3862'}]}]}, {'title': 'tetanus toxoid', 'categories': [{'measurements': [{'value': '-0.1071', 'groupId': 'OG000', 'lowerLimit': '-0.6035', 'upperLimit': '0.4491'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.', 'unitOfMeasure': 'Pearson correlation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Colony Stimulating Factor and Chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nsargramostim: Given SC\n\npaclitaxel albumin-stabilized nanoparticle formulation: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunologic technique: Correlative studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2007-04-25', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2007-04-25', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-24', 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'Up to 5 years', 'description': 'Median time to progression'}, {'measure': 'Response Rate', 'timeFrame': 'Up to 5 years', 'description': 'Number of patients achieving a complete or partial response.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Circulating Monocytes and Time to Progression', 'timeFrame': 'Up to 5 years', 'description': 'Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).'}, {'measure': 'Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration', 'timeFrame': 'Up to 5 years', 'description': 'Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).'}, {'measure': 'Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens', 'timeFrame': 'Up to 5 years', 'description': 'Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.'}, {'measure': 'Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens', 'timeFrame': 'Up to 5 years', 'description': 'Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brenner Tumor', 'Fallopian Tube Cancer', 'Ovarian Clear Cell Cystadenocarcinoma', 'Ovarian Endometrioid Adenocarcinoma', 'Ovarian Mixed Epithelial Carcinoma', 'Ovarian Mucinous Cystadenocarcinoma', 'Ovarian Serous Cystadenocarcinoma', 'Ovarian Undifferentiated Adenocarcinoma', 'Peritoneal Cavity Cancer', 'Recurrent Ovarian Epithelial Cancer', 'Stage III Ovarian Epithelial Cancer', 'Stage IV Ovarian Epithelial Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.\n\nPURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous chemotherapy', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer.\n\nII. To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells, such as dendritic cells and activated monocytes, in patients with advanced epithelial ovarian cancer.\n\nIII. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer.\n\nIV. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer.\n\nOUTLINE:\n\nINDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up monthly for 6 months and then every 3 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have histologically proven epithelial ovarian, fallopian tube or primary peritoneal malignancies, excluding tumors of low malignant potential (borderline)\n* Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified\n* Patients must have either primary platinum refractory or resistant carcinoma or secondary platinum resistant disease:\n\n 1. Primary platinum refractory disease is defined as progression of disease on initial platinum-based chemotherapy or persistent disease at the conclusion of the initial platinum-based chemotherapy course associated with the primary debulking surgery.\n 2. Primary platinum resistant disease is defined as recurrence of carcinoma within 6 months (+ 14 days) of completion of initial platinum-based chemotherapy associated with the primary debulking surgery. (The 14 day window is to allow study entry for those patients where evidence clearly suggests that had an assessment been made early the patient would have met the 6 month time line. This will be determined by the study principal investigator \\[P.I.\\])\n 3. Secondary platinum resistant disease is defined as meeting any one of the listed criteria during or following a subsequent platinum containing regimen.\n* Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater than 7 days apart\n* Absolute neutrophil count \\>= 1500/uL\n* Platelets \\>= 100,000/uL\n* Creatinine =\\< 2.0 mg/dL\n* Total bilirubin =\\< 1.5 mg/dL (unless history of Gilbert's disease)\n* Serum glutamic oxaloacetic transaminase (SGOT) =\\< 2.5 x upper limit of normal (ULN) or \\< 5 x ULN with documented report of hepatic metastases\n* Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least three weeks must have elapsed since prior chemotherapy or radiation therapy\n\nExclusion Criteria:\n\n* Patient has an allergic history to paclitaxel or GM-CSF, not manageable by pre-medication and/or slow drug infusion\n* Patient has poorly controlled arrhythmias or unstable coronary artery disease or has had a myocardial infarction within the last six months\n* Patient with active pulmonary edema or pleural effusion\n* Active infection requiring IV antibiotics\n* Patient currently requires lithium, (due to drug interaction with GM-CSF \\[Leukine\\])\n* Patient currently presents with a neurotoxicity \\> Grade 1\n* Women of childbearing potential\n* Patients with a history of other invasive malignancies, within the previous 5 years are excluded, with the exception of non-melanoma skin cancer"}, 'identificationModule': {'nctId': 'NCT00466960', 'briefTitle': 'Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer', 'orgStudyIdInfo': {'id': '6168'}, 'secondaryIdInfos': [{'id': 'NCI-2010-00556', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (colony stimulating factor and chemotherapy)', 'description': 'INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: sargramostim', 'Drug: paclitaxel albumin-stabilized nanoparticle formulation', 'Other: laboratory biomarker analysis', 'Other: immunologic technique']}], 'interventions': [{'name': 'sargramostim', 'type': 'BIOLOGICAL', 'otherNames': ['GM-CSF', 'Leukine', 'Prokine'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (colony stimulating factor and chemotherapy)']}, {'name': 'paclitaxel albumin-stabilized nanoparticle formulation', 'type': 'DRUG', 'otherNames': ['ABI-007', 'nab paclitaxel', 'nab-paclitaxel', 'nanoparticle albumin-bound paclitaxel'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (colony stimulating factor and chemotherapy)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (colony stimulating factor and chemotherapy)']}, {'name': 'immunologic technique', 'type': 'OTHER', 'otherNames': ['immunological laboratory methods', 'laboratory methods, immunological'], 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (colony stimulating factor and chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Barbara Goff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barbara Goff', 'investigatorAffiliation': 'University of Washington'}}}}