Overview

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.