Status:
COMPLETED
Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Colorectal Cancer
Eligibility:
All Genders
75-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, 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 * Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorour...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease
- Unresectable disease
- Measurable disease that is outside the field of prior irradiation
- No brain metastases
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Transaminases ≤ 5 times normal
- Bilirubin ≤ 1.5 times normal
- Alkaline phosphatase \< 3 times normal (5 times normal if due to hepatic involvement)
- Creatinine clearance \> 45 mL/min
- Life expectancy \> 3 months
- No psychological, social, or geographical situation that would preclude study treatment
- No chronic diarrhea or enteropathy
- No coronary insufficiency or symptomatic cardiac disease
- No other malignancy unless curatively treated
- No contraindication to chemotherapy
- PRIOR CONCURRENT THERAPY:
- At least 6 months since prior adjuvant chemotherapy for the primary tumor
- No prior extensive resection
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00303771
Start Date
June 1 2003
End Date
January 1 2011
Last Update
May 30 2016
Active Locations (77)
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1
Centre Hospitalier d'Abbeville
Abbeville, France, 80101
2
Centre Hospitalier D'Agen
Agen, France, 47923
3
Centre hospitalier d'Alencon
Alençon, France, 61000
4
Clinique De Rochebelle
Alès, France, F-30100