Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

• Stage IV

• Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.

• Absence or irradiated and stable central nervous system metastatic disease.

• Life expectancy of more than 3 months.

• Age ≥ 70 years.

• Performance status (WHO) ≤ 2.

• Adequate bone marrow function (Absolute neutrophil count >1000/mm3, Platelet count >100000/mm3, Hemoglobin >9gr/mm3).

• Adequate liver (Bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal).

• Creatinine clearance (Cockcroft-Gault formula) >30ml/min.

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

• Presence of a reliable care giver.

• Informed consent.

Exclusion Criteria:

• Prior chemotherapy for metastatic disease.

• History of thromboembolic disease or myocardial infraction within the last 6 months.

• Peripheral neuropathy ≥ grade 2.

• Bowel obstruction or chronic diarrhea.

• Psychiatric illness or social situation that would preclude study compliance.

• Other concurrent uncontrolled illness.

• Other concurrent investigational agents.