A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Hellenic Oncology Research Group6 sites in 1 country46 target enrollmentMarch 2006

ConditionsMetastatic Colorectal Cancer

InterventionsOxaliplatin Capecitabine Bevacizumab

DrugsOxaliplatin Capecitabine Bevacizumab

Overview

Phase: Phase 2
Intervention: Oxaliplatin
Conditions: Metastatic Colorectal Cancer
Sponsor: Hellenic Oncology Research Group
Enrollment: 46
Locations: 6
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hellenic Oncology Research Group

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
•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) ≤
•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.

Exclusion Criteria

•Prior chemotherapy for metastatic disease.
•History of thromboembolic disease or myocardial infraction within the last 6 months.
•Peripheral neuropathy ≥ grade
•Bowel obstruction or chronic diarrhea.
•Psychiatric illness or social situation that would preclude study compliance.
•Other concurrent uncontrolled illness.
•Other concurrent investigational agents.