Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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 alone arm in the first-line treatment of MCRC in patients aged 75 years and older.

This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Dijon
• Treatments: Bevacizumab; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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