Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-30 @ 7:57 AM
Study NCT ID:
NCT00030706
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2002-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], '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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2002-02-14', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of clinical remission', 'timeFrame': 'up to 12-months post-treatment', 'description': 'number of participants experience clinical remission will be determined'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer', 'peritoneal cavity cancer'], 'conditions': ['Ovarian Cancer', 'Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer.\n* Determine the nature and degree of toxicity of this drug in these patients.\n\nSecondary\n\n* Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response).\n* Correlate CYP3A4 (3A4\\*1B), 3A5 (3A5\\*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma\n\n * Recurrent or refractory disease\n\n * Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel\n * Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment\n* Bidimensionally measurable disease by physical exam, CT scan, or MRI\n\n * Ascites and pleural effusions are not measurable disease\n * No prior irradiation to indicator lesions\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 75\n\nPerformance status\n\n* GOG 0-2\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* No prior bleeding disorder or unexplained bleeding\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT/SGPT no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal\n\n* Creatinine no greater than 1.5 times ULN\n\nOther\n\n* No active infection requiring antibiotics\n* No grade 2 or greater neuropathy (sensory and motor)\n* No other malignancy within the past 5 years except nonmelanoma skin cancer\n* No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel\n* No other medical condition that would preclude study participation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy and recovered\n* No prior ixabepilone\n* No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma\n\nEndocrine therapy\n\n* At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma\n* Concurrent hormonal replacement therapy allowed\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiotherapy and recovered\n* No prior radiotherapy to a site of measurable disease used on study\n* No prior radiotherapy to more than 25% of bone marrow\n\nSurgery\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther\n\n* At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma\n* No prior cancer treatment for other invasive malignancies that would preclude study participation\n* No concurrent heparin or other anticoagulants\n* No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound"}, 'identificationModule': {'nctId': 'NCT00030706', 'briefTitle': 'Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'CDR0000069190'}, 'secondaryIdInfos': [{'id': 'P30CA013330', 'link': 'https://reporter.nih.gov/quickSearch/P30CA013330', 'type': 'NIH'}, {'id': 'AECM-3632'}, {'id': 'MCC-12602'}, {'id': 'NCI-3632'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ixabepilone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein Cancer Center at Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Gary L. Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}