Status:
TERMINATED
Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Centre Alexis Vautrin, Nancy
Conditions:
Colorectal Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal adenocarcinoma meeting the following criteria:
- Exclusively peritoneal carcinomatosis (no other metastases)
- Resectable disease
- Primary tumor may be same in the same location as another synchronous carcinomatosis
- Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Creatinine ≤ 1.25 times ULN
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil
- No other noncancerous disease that would preclude study therapy
- Good nutritional status
- No sensitive peripheral neuropathy with functional impairment
- No hypoplasia or bone marrow failure
- No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction)
- No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer
- No patients deprived of liberty or under supervision
- No psychological, social, familial, or geographical reasons prohibiting follow-up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab
- No prophylactic phenytoin (Dihydan®, Dilantin®)
- No prior yellow fever vaccine
- More than 1 month since participation in another study
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00766142
Start Date
May 1 2007
End Date
September 17 2013
Last Update
August 29 2025
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076