Status:
COMPLETED
Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or ...
Detailed Description
OBJECTIVES: Primary * Compare disease-control duration in patients with metastatic colorectal cancer receiving FOLFIRI chemotherapy in combination with bevacizumab with or without bevacizumab mainte...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Metastatic disease
- Not a candidate for curative surgery
- At least 1 tumor target measurable by RECIST criteria
- No metastasis potentially resectable after receiving chemotherapy
- No occlusive tumors
- No macronodular peritoneal carcinomatosis
- No known or suspected CNS metastases
- PATIENT CHARACTERISTICS:
- OMS status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
- Creatinine ≤ 1.5 times ULN
- Proteinuria ≤1 g
- Not pregnant or nursing
- No gastroduodenal ulcer, wound, or fractured bone
- No acute or subacute intestinal occlusion or history of inflammatory bowel disease or large resection of small bowel
- No clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
- No uncontrolled hypertension while receiving chronic medication
- No other malignancy within the past 5 years except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- No medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study
- PRIOR CONCURRENT THERAPY:
- See Patient Characteristics
- No prior chemotherapy for metastatic disease
- Adjuvant chemotherapy allowed provided it was completed \> 6 months ago
- No prior irinotecan or other antiangiogenic therapy
- At least 4 weeks since surgery (except for diagnostic biopsy) or irradiation
- No other drugs not allowed for medical reasons
- Concurrent oral anticoagulants (e.g., coumadin, warfarin) allowed provided the INR is closely monitored
- A change of anticoagulants to low-molecular weight heparin is preferred
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00952029
Start Date
March 1 2010
End Date
January 1 2018
Last Update
March 30 2020
Active Locations (102)
Enter a location and click search to find clinical trials sorted by distance.
1
CH
Abbeville, France
2
Centre Radiothérapie et Oncologie de Moyenne Garonne
Agen, France
3
CHU
Amiens, France
4
Centre Paul Papin
Angers, France