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

Date de début de l'étude : 1 juin 2004

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent disease * Measurable disease * 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 * Target lesion not within previously irradiated field * Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound * Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel * Platinum-sensitive disease * Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen * 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 * Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking * Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No uncontrolled hypertension * No unstable angina * No congestive heart failure * No uncontrolled arrhythmias within the past 6 months * No other significant cardiac disease Neurologic * No uncontrolled seizure disorder * No active neurological disease * No neuropathy \> grade 1 Other * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No active infection requiring antibiotics * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-epidermal growth factor receptor (EGFR) antibody therapy * No prior chimerized or murine monoclonal antibody therapy * At least 3 weeks since prior biologic or immunologic therapy for the malignancy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens Endocrine therapy * At least 1 week since prior hormonal therapy for the malignancy * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to \> 25% of bone marrow-bearing areas Surgery * More than 30 days since prior major surgery and recovered * Diagnostic biopsy not considered major surgery Other * At least 3 weeks since other prior therapy for the malignancy * No prior tyrosine kinase inhibitors that target the EGFR pathway * No prior cancer treatment that would preclude study treatment * No other concurrent investigational agents