Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 1:20 AM
Study NCT ID:
NCT00004066
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'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': '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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adult leiomyosarcoma', 'recurrent adult soft tissue sarcoma', 'small intestine leiomyosarcoma', 'stage IV uterine sarcoma', 'recurrent uterine sarcoma', 'uterine leiomyosarcoma', 'ovarian sarcoma', 'recurrent small intestine cancer', 'stage IV adult soft tissue sarcoma'], 'conditions': ['Ovarian Cancer', 'Sarcoma', 'Small Intestine Cancer']}, 'referencesModule': {'references': [{'pmid': '12065559', 'type': 'RESULT', 'citation': 'Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31. doi: 10.1200/JCO.2002.11.050.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.\n\nPURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, docetaxel, and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery.", 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim (G-CSF) support, in terms of disease response, in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma.\n* Determine the tolerability of this regimen in these patients.\n* Correlate response with tumor expression of the apoptosis-regulating proteins bax, bcl-2, and survivin in these patients.\n\nOUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).\n\nPatients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response may receive 2 additional courses of therapy.\n\nPatients are followed every 3 months for 1 year or until disease progression.\n\nPROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed leiomyosarcoma (LMS) or other soft tissue sarcoma\n\n * No gastrointestinal stromal tumors, chondrosarcoma, Kaposi's sarcoma, Ewing's sarcoma, osteosarcoma, or mesotheliomas\n* Recurrent or progressive disease defined as an increase in the size of any existing tumor (or the development of new tumors) that is not amenable to definitive surgical therapy\n* No prior chemotherapy OR\n* Failed no more than 2 prior chemotherapy regimens for LMS of the uterus or other soft tissue sarcoma\n* Bidimensionally measurable disease by physical examination or medical imaging techniques\n\n * Ascites and pleural effusions are not considered measurable disease\n* No uncontrolled CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nOther:\n\n* No active or uncontrolled infection\n* No other prior malignancy except non-metastatic squamous cell or basal cell skin cancer or non-invasive carcinoma in situ of the cervix\n* No history of grade 3 or 4 peripheral neuropathy\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy\n* No prior gemcitabine or docetaxel\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 6 weeks since prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00004066', 'briefTitle': 'Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma', 'orgStudyIdInfo': {'id': '99-027'}, 'secondaryIdInfos': [{'id': 'P30CA008748', 'link': 'https://reporter.nih.gov/quickSearch/P30CA008748', 'type': 'NIH'}, {'id': 'MSKCC-99027'}, {'id': 'NCI-G99-1576'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert Maki, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}