Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT00003732
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian 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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-07', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose and dose-limiting toxicity of topotecan'}, {'measure': 'Toxic effects'}, {'measure': 'Antitumor activity'}]}, 'conditionsModule': {'keywords': ['stage IIB ovarian epithelial cancer', 'stage IIC ovarian epithelial cancer', 'stage IIIA ovarian epithelial cancer', 'stage IIIB ovarian epithelial cancer', 'stage IIIC ovarian epithelial cancer', 'stage IV ovarian epithelial cancer'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00)\n* Evaluate the anti-tumor activity of this regimen in this patient population.\n\nOUTLINE: This is a multicenter, dose-escalation study of topotecan.\n\nPatients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.\n\n* Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00)\n* Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer\n* Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients)\n* No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Hemoglobin at least 9.0 g/dL\n* WBC at least 3,500/mm3\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present\n* Alkaline phosphatase no greater than 2 times ULN\\*\n* SGOT no greater than 2 times ULN\\* NOTE: \\*No greater than 5 times ULN if liver metastases present\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment\n* No myocardial infarction within the past 3 months\n\nOther:\n\n* No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix\n* No uncontrolled infection\n* No complete bowel obstruction or other condition that would affect GI absorption or motility\n* No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated\n* No other concurrent medical conditions that would preclude study\n* No mental disease\n* No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K)\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No prior camptothecin analogue\n* No prior chemotherapy for ovarian cancer\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent hormonal therapy other than estrogen replacement\n\nRadiotherapy:\n\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 30 days or 5 half-lives since any prior investigational therapy\n* No other concurrent investigational therapy\n* No concurrent metoclopramide or cisapride'}, 'identificationModule': {'nctId': 'NCT00003732', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV', 'orgStudyIdInfo': {'id': 'DAN-104864/373'}, 'secondaryIdInfos': [{'id': 'CDR0000066847', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'DAN-104864-A/373'}, {'id': 'EU-98052'}, {'id': 'SB-104864-A/373'}, {'id': 'SB-104864/373'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'paclitaxel', 'type': 'DRUG'}, {'name': 'topotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet - Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Svend Aage Engelholm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}