Status:
COMPLETED
Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or c...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent ca...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous or non-squamous cell carcinoma of the cervix
- Advanced, persistent, or recurrent disease
- Documented disease progression
- Not amenable to curative therapy
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion
- Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- GOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Platelet count ≥ 100,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No significant history of cardiac disease within the past 6 months, including the following:
- Unstable angina
- Uncontrolled hypertension
- Uncontrolled congestive heart failure
- Uncontrolled arrhythmia
- Neurologic
- No uncontrolled seizure disorder
- No active neurological disease
- No neuropathy (sensory and motor) \> grade 1
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
- No prior chimerized or murine monoclonal antibody therapy
- Chemotherapy
- Not specified
- Endocrine therapy
- At least 1 week since prior anticancer hormonal therapy
- Concurrent hormone replacement therapy allowed
- Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- Surgery
- More than 30 days since prior major surgery, except diagnostic biopsy
- Other
- Recovered from all prior therapy
- No prior cytotoxic therapy for cervical cancer
- No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway
- No prior cancer treatment that would contraindicate study therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00101192
Start Date
September 1 2004
Last Update
March 17 2014
Active Locations (18)
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1
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
4
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289