Status:
COMPLETED
Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
UNICANCER
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, 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...
Detailed Description
OBJECTIVES: Primary * Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotec...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Unresectable metastatic disease
- Measurable disease
- No CNS metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy \> 3 months
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 9 g/dL (transfusion allowed)
- INR \< 1.5
- Alkaline phosphatase \< 1.5 times upper limit of normal (ULN)
- Bilirubin \< 1.5 times ULN
- AST and ALT \< 2.5 times ULN (5 times ULN if liver metastases are present)
- Creatinine clearance \> 30 mL/min
- Urine protein \< 2+ OR ≤ 1 g/L by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindications to study therapy
- No gastrointestinal or duodenal ulcers
- No AIDS
- No serious illness, active infection, or other serious condition that would preclude study therapy
- No coagulation problem
- No bleeding diathesis
- No sensitivity to Chinese hamster ovarian cells or other recombinant human antibodies
- No severe renal insufficiency
- No uncontrolled hypertension
- No active or severe cardiovascular conditions, including the following:
- Cerebrovascular accident
- Myocardial infarction within the past 6 months
- New York Heart Association class II-IV cardiac insufficiency
- Severe cardiac arrhythmia (even if treated)
- No primitive stenosis or symptomatic peritoneal carcinosis causing a risk of intestinal subocclusion or occlusion
- No nonhealing wound or fracture
- No prior thromboembolic disease
- No other cancer within the past 2 years except for basal cell skin cancer or carcinoma in situ of the uterine cervix
- No geographical, social, or psychological condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- At least 6 months since prior adjuvant chemotherapy (fluorouracil with or without oxaliplatin)
- No prior adjuvant chemotherapy comprising irinotecan hydrochloride with or without bevacizumab
- At least 28 days since prior major surgery
- Prior radiotherapy allowed except to target lesions
- At least 10 days since prior anticoagulants
- No concurrent chronic acetylsalicylic acid (at doses \> 325 mg/day)
- No other concurrent investigational therapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
March 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00423696
Start Date
March 23 2006
End Date
August 1 2011
Last Update
February 17 2021
Active Locations (15)
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1
C.H.U. de Brest
Brest, France, 29200
2
Centre Regional Francois Baclesse
Caen, France, 14076
3
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
4
Centre Oscar Lambret
Lille, France, 59020