Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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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. PURPOSE: 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.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer. Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients 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. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Official Title
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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

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: cetuximab
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: cetuximab|nan|
|Drug: carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer