Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 6:38 PM
Study NCT ID:
NCT00052468
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2003-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian 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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C053518', 'term': 'CP protocol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1742}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2003-01-24', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Whole Study Period'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Whole Study Period', 'description': 'Survival time is calculated from the date of enrollment into the study until the date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Whole Study Period', 'description': 'The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I ovarian epithelial cancer', 'stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'fallopian tube cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '20733132', 'type': 'RESULT', 'citation': 'du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.'}, {'pmid': '21410972', 'type': 'DERIVED', 'citation': 'Machelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.\n\nPURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.\n* Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.\n* Compare toxic effects of these regimens in these patients.\n* Compare quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.\n* Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.\n\nSome patients undergo interval debulking surgery.\n\nQuality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.\n\nPatients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of one of the following:\n\n * Ovarian epithelial cancer\n\n * FIGO stage IA/B G3, IC-IV\n * Fallopian tube cancer\n * Extra-ovarian papillary serous tumor\n* The following are ineligible:\n\n * Low malignant-potential ovarian tumors (borderline tumors)\n * Non-epithelial ovarian tumors\n * Mixed Mullerian tumors\n* Must have had definitive surgery within the past 6 weeks\n* No symptomatic brain metastases\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 6 months\n\nHematopoietic\n\n* WBC at least 3,000/mm\\^3 OR\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin greater than 10 mg/dL\n\nHepatic\n\n* Bilirubin no greater than 2 times upper limit of normal\n\nRenal\n\n* Glomerular filtration rate at least 50 mL/min\n\nCardiovascular\n\n* No congestive heart failure\n* No myocardial infarction within the past 6 months\n* No New York Heart Association class III or IV heart disease\n* No prior atrial or ventricular arrhythmias\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No prior seizures or central nervous system disorder\n* No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)\n* No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel\n* No preexisting motor or sensory neuropathy greater than grade 1\n* No other malignancy within the past 5 years except:\n\n * Malignancies cured by surgery alone\n * Carcinoma in situ of the cervix\n * Adequately treated basal cell skin cancer\n* No complete bowel obstruction\n* No other concurrent severe medical condition that would preclude study participation\n* No dementia or significantly altered mental status that would preclude study participation\n* No concurrent severe active infection\n* Geographically accessible for treatment and follow-up\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunotherapy\n\nChemotherapy\n\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy except:\n\n * Hormone replacement therapy\n * Antiemetic steroids\n\nRadiotherapy\n\n* No prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther\n\n* No other concurrent antineoplastic agents\n* No other concurrent investigational drugs\n* No other concurrent clinical trial enrollment'}, 'identificationModule': {'nctId': 'NCT00052468', 'acronym': 'AGO-OVAR9', 'briefTitle': 'Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AGO Study Group'}, 'officialTitle': 'A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV', 'orgStudyIdInfo': {'id': 'CDR0000258429'}, 'secondaryIdInfos': [{'id': 'AGO-OVAR9'}, {'id': 'NORDIC-AGO-OVAR-9'}, {'id': 'GERCOR-AGO-OVAR-9'}, {'id': 'EU-20241'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCG', 'description': 'Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses', 'interventionNames': ['Drug: TCG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TC', 'description': 'Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses', 'interventionNames': ['Drug: TC']}], 'interventions': [{'name': 'TCG', 'type': 'DRUG', 'otherNames': ['Paclitaxel/Carboplatin/Gemcitabine'], 'armGroupLabels': ['TCG']}, {'name': 'TC', 'type': 'DRUG', 'otherNames': ['Paclitaxel/Carboplatin'], 'armGroupLabels': ['TC']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK2730', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital - University Hospital of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '75181', 'city': 'Paris', 'country': 'France', 'facility': 'Hotel Dieu de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Zentralkrankenhaus', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': 'DOH-40217', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-65929', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Staedtische Kliniken Frankfurt am Main - Hoechst', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '30659', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Frauenklinik der MHH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-76137', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Vincentius Krankenhaus', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein - Kiel Campus', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '39108', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': 'D-81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum Rechts Der Isar - Technische Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-48129', 'city': 'Münster', 'country': 'Germany', 'facility': 'Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'D-89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitaet Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'D-65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Dr. Horst-Schmidt-Kliniken', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': 'N-0310', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian Radium Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Andreas du Bois, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dr. Horst-Schmidt-Kliniken'}, {'name': 'J. Herrstedt', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen County Herlev University Hospital'}, {'name': 'E. Pujade-Lauraine, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hotel Dieu de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGO Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nordic Society of Gynaecological Oncology - Clinical Trials Unit', 'class': 'OTHER'}, {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}