Status:
COMPLETED
Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Metastatic Colorectal Adenocarcinoma
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy...
Eligibility Criteria
Inclusion
- Patients aged 75 years or older
- ECOG ≤2
- histologically proven unresectable metastatic colorectal adenocarcinoma
- Measurable lesion according to RECIST criteria
- Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
- Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
- Completed geriatric self-questionnaire
- Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
- Written informed consent
Exclusion
- Estimated life expectancy \< 3 months
- Non-resolved intestinal occlusion or sub-occlusion
- Cerebral metastasis
- Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
- Evolutive gastroduodenal ulcer, wound or bone fracture
- Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
- Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
- Polynuclear neutrophils \<1500/mm3, platelets \<100 000/mm3 or 24-h proteinuria \> 1g
- History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
- History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
- History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
- Impossibility to ensure regular follow-up
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01900717
Start Date
July 1 2011
End Date
March 1 2016
Last Update
December 27 2018
Active Locations (1)
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1
CHU de Dijon
Dijon, France, 21079