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
Data Collection
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 75 locations
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesSee the locationCCOP - Western Regional, Arizona
Phoenix, United StatesJonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesWomen's Cancer Center - Los Gatos
Los Gatos, United States