Status:
COMPLETED
1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Colorectal Cancer
Eligibility:
All Genders
75-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing ...
Detailed Description
OBJECTIVES: Primary * To evaluate composite efficacy and safety, in terms of objective response or tumoral stability by RECIST criteria and no deterioration in the Spitzer QoL Index score of ≥ 2 poi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic colorectal adenocarcinoma
- Unresectable disease
- Measurable disease by RECIST criteria
- No cerebral metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Polynuclear neutrophils \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Proteinuria ≤ 1 g on 24-hour urine collection
- No unresolved intestinal occlusion or subocclusion
- No other progressive or unstabilized malignant tumor within the past 2 years
- No progressive gastroduodenal ulcer, wound, or bone fracture
- No active cardiac disease including any of the following:
- Hypertension not adequately controlled
- Myocardial infarction within the past 6 months
- Poorly controlled angina
- Decompensated congestive cardiac insufficiency
- No history of arterial thromboembolism or any of the following within the past 12 months:
- Cerebrovascular accident
- Transient ischemic attack
- Subarachnoid hemorrhage
- No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
- No history of life-threatening pulmonary embolism within the past 6 months
- Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- More than 6 months since adjuvant chemotherapy after resection of the primary tumor
- More than 4 weeks since major surgery, excluding biopsy
- More than 4 weeks since radiotherapy
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01417494
Start Date
July 1 2011
End Date
April 1 2016
Last Update
November 3 2020
Active Locations (1)
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1
Hôpital Avicenne
Bobigny, France, 93000