Status:
COMPLETED
Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Conditions:
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00086892
Start Date
June 1 2004
Last Update
February 14 2014
Active Locations (76)
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1
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
3
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1740
4
Women's Cancer Center - Los Gatos
Los Gatos, California, United States, 95032