Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT00047632
Status:
TERMINATED
Last Update Posted:
2007-11-01
First Post:
2002-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554125', 'term': 'interferon gamma-1b'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 847}}, 'statusModule': {'whyStopped': 'futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2002-10-09', 'studyFirstSubmitQcDate': '2002-10-10', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival time assessed at end of study', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival time assessed at interim analysis', 'timeFrame': '4 years'}, {'measure': 'Treatment failure-free survival time assessed at end of study', 'timeFrame': '4 years'}, {'measure': 'Quality of life assessed through 24 months after end of treatment', 'timeFrame': '4 years'}]}, 'conditionsModule': {'keywords': ['ovarian', 'carcinoma', 'peritoneal', 'cancer', 'ovary', 'interferon gamma'], 'conditions': ['Ovarian Carcinoma', 'Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the progression or return of cancer; 3) the effects on quality of life; and 4) the safety of interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.', 'detailedDescription': "Approximately 800 patients will receive either chemotherapy alone or chemotherapy plus Interferon gamma-1b. Chemotherapy will be paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. Only those patients in the treatment arm will receive interferon doses. Interferon gamma-1b 100 mg will be administered subcutaneously 3 times per week (every other day; no more than 3 doses in a 7-day period) continuously while patients are treated with carboplatin / paclitaxel (including for the 3 weeks following the last dose of chemotherapy). A total of 6 cycles of chemotherapy will be given unless disease progression or liming toxicity occurs or patients refuse further treatment. Each patient will receive a total of 54 doses over a period of 18 weeks. Each patient's participation will be from 3-8 years in duration."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (\\<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.\n* Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.\n* \\<= 12 weeks after initial surgery with adequate recovery from surgery.\n* Candidate for first-line chemotherapy\n* Adequate bone marrow function (ANC \\>= 1,500/mL; platelets \\>= 100,000/mL; hemoglobin \\>= 10 gm/dL)\n* Adequate hepatic function (AST, ALT, and alkaline phosphatase \\<= 2.5 x upper limit of normal; bilirubin \\<= 1.5 x upper limit of normal).\n* Adequate renal function (creatinine \\<= 1.5 x upper limit of normal).\n* Adequate neurologic function (sensory and motor neuropathy \\<= NCI CTC Grade 1).\n* Negative urine pregnancy test in women of child-bearing potential (within 14 days of the initiation of the first chemotherapy cycle).\n* Zubrod / ECOG / GOG performance score 0-2.\n* Able to give informed consent.\n\nExclusion criteria:\n\n* Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone \\[(e.g., fine needle aspiration (FNA)\\], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.\n* Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.\n* Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.\n* Prior biological response modifier (BRM) for any reason within the previous 5 years.\n* Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy \\> 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.\n* Uncontrolled infection.\n* Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the dosing portion of the study.\n* Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints."}, 'identificationModule': {'nctId': 'NCT00047632', 'briefTitle': 'Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'InterMune'}, 'officialTitle': 'Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.', 'orgStudyIdInfo': {'id': 'GIOV-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon gamma-1b', 'type': 'DRUG', 'description': '100 mcg, SQ, 3x per week'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94005', 'city': 'Brisbane', 'state': 'California', 'country': 'United States', 'facility': 'InterMune, Inc.', 'geoPoint': {'lat': 37.68077, 'lon': -122.39997}}], 'overallOfficials': [{'name': 'InterMune, Inc. 888-486-6411', 'affiliation': 'Medical Information'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InterMune', 'class': 'INDUSTRY'}}}}