Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 7:23 AM
Study NCT ID:
NCT00217568
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity 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': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-20', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'Response rates (complete and partial response)'}, {'measure': 'Relapse rates'}, {'measure': 'Event-free survival'}, {'measure': 'Overall survival'}]}, 'conditionsModule': {'keywords': ['recurrent ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'peritoneal cavity cancer'], 'conditions': ['Ovarian Cancer', 'Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.\n* Determine the response rates (complete and partial response) in patients treated with this regimen.\n* Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.\n\nAfter completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer\n\n * Stage III or IV disease\n * No borderline tumors\n* Measurable or evaluable disease\n\n * Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation\n * Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)\n* In first relapse\n\n * Platinum-sensitive disease, defined as initial relapse \\> 6 months after completion of a platinum-based regimen\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* Platelet count ≥ 100,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n\nHepatic\n\n* Bilirubin normal\n* Meets 1 of the following criteria:\n\n * SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN\n * SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL\n* Creatinine clearance \\> 50 mL/min\n\nCardiovascular\n\n* LVEF ≥ 50%\n* No poorly controlled arrhythmia\n* No unstable coronary artery disease or myocardial infarction within the past year\n\nOther\n\n* HIV negative\n* No pre-existing peripheral neuropathy \\> grade 2\n* No history of allergy to study drugs\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 and recovered\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* Recovered from recent prior surgery\n\nOther\n\n* No concurrent myelosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT00217568', 'briefTitle': 'Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma', 'orgStudyIdInfo': {'id': 'PSOC 1702'}, 'secondaryIdInfos': [{'id': 'PSOC-1702'}, {'id': 'AVENTIS-PSOC-1702'}, {'id': 'PSOC-IRB-4861'}, {'id': 'CDR0000441307', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pegfilgrastim', 'type': 'BIOLOGICAL'}, {'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific Gynecology Specialists', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Leona A. Holmberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}