Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT00086892
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2004-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal 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': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2004-07-08', 'studyFirstSubmitQcDate': '2004-07-09', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent ovarian epithelial cancer', 'primary peritoneal cavity cancer'], 'conditions': ['Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']}, 'referencesModule': {'references': [{'pmid': '18191993', 'type': 'RESULT', 'citation': 'Secord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.\n* Determine the nature and degree of toxicity of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial or primary peritoneal cancer\n\n * Recurrent disease\n* Measurable disease\n\n * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan\n * Target lesion not within previously irradiated field\n* Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound\n\n * Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment\n * Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel\n* Platinum-sensitive disease\n\n * Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen\n * If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol\\* NOTE: \\*Applies whether or not both protocols are available at the same participating center\n* Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking\n* Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* GOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* SGOT ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No uncontrolled hypertension\n* No unstable angina\n* No congestive heart failure\n* No uncontrolled arrhythmias within the past 6 months\n* No other significant cardiac disease\n\nNeurologic\n\n* No uncontrolled seizure disorder\n* No active neurological disease\n* No neuropathy \\> grade 1\n\nOther\n\n* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer\n* No active infection requiring antibiotics\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior anti-epidermal growth factor receptor (EGFR) antibody therapy\n* No prior chimerized or murine monoclonal antibody therapy\n* At least 3 weeks since prior biologic or immunologic therapy for the malignancy\n\nChemotherapy\n\n* See Disease Characteristics\n* Recovered from prior chemotherapy\n* No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens\n\nEndocrine therapy\n\n* At least 1 week since prior hormonal therapy for the malignancy\n* Concurrent hormone replacement therapy allowed\n\nRadiotherapy\n\n* See Disease Characteristics\n* Recovered from prior radiotherapy\n* No prior radiotherapy to \\> 25% of bone marrow-bearing areas\n\nSurgery\n\n* More than 30 days since prior major surgery and recovered\n\n * Diagnostic biopsy not considered major surgery\n\nOther\n\n* At least 3 weeks since other prior therapy for the malignancy\n* No prior tyrosine kinase inhibitors that target the EGFR pathway\n* No prior cancer treatment that would preclude study treatment\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00086892', 'briefTitle': 'Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer', 'orgStudyIdInfo': {'id': 'GOG-0146P'}, 'secondaryIdInfos': [{'id': 'BMS-CA225-019'}, {'id': 'CDR0000371712'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL'}, {'name': 'carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at University of Alabama at Birmingham', 'geoPoint': {'lat': 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Secord, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}, {'name': 'Deborah K. Armstrong, MD', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, {'name': 'Nita Maihle, PhD', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}