Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-03 @ 12:18 PM
Study NCT ID:
NCT00189566
Status:
COMPLETED
Last Update Posted:
2011-02-25
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], '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': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-24', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival of patients in the three groups'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Rate of response and rate of progression at the end of treatment'}, {'measure': 'Qualitative and quantitative toxicities'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['Relapse within 6 months', 'Previously received taxane derivative'], 'conditions': ['Ovarian Cancer', 'Fallopian Tube Cancer', 'Malignant Tumor of Peritoneum']}, 'descriptionModule': {'briefSummary': 'This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.', 'detailedDescription': 'The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol\\*) weekly administered, in lower doses in combination with topotecan (Hycamtin\\*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 18\n* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum\n* Peritoneal and/or nodes and/or visceral metastases\n* Disease in progression under treatment or within 6 months after a first or second platinum-based line\n* A period of 3 weeks between last chemotherapy and inclusion\n* Measurable disease (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \\[GCIG\\] criteria)\n* ECOG performance status \\< 2\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Previously received weekly administration of paclitaxel chemotherapy\n* Involved in a trial within the last 30 days\n* Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy\n* Prior diagnosis of malignancy\n* History of ischemic cardiopathy, congestive heart failure (New York Heart Association \\[NYHA\\] \\> 2), arrhythmia, hypertension, or significant valvulopathy\n* Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\n* Bone marrow, renal, or hepatic insufficiency\n* Severe active infection or occlusive or sub-occlusive disease\n* History of symptomatic brain metastases\n* Fertile women not using adequate contraceptive methods\n* Pregnant or breast feeding women\n* Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin'}, 'identificationModule': {'nctId': 'NCT00189566', 'briefTitle': 'Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse', 'organization': {'class': 'OTHER', 'fullName': 'ARCAGY/ GINECO GROUP'}, 'officialTitle': 'National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse', 'orgStudyIdInfo': {'id': 'CAR\\TAXHY'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG'}, {'name': 'Topotecan', 'type': 'DRUG'}, {'name': 'Carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Laure Chauvenet, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Hôtel Dieu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCAGY/ GINECO GROUP', 'class': 'OTHER'}}}}