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

Inclusion Criteria

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