Trial Information

Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70

OBJECTIVES:

Primary

- Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as
defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living
scale, in older patients with metastatic colorectal adenocarcinoma.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the percentage of patients who receive the first 3 courses of this regimen
(at lower doses) and the percentage of patients who receive all 6 courses of this
regimen (at both lower and higher doses).

- Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients receive oral capecitabine* once daily on days 1-14 and oxaliplatin* IV on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

NOTE: *The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the
absence of unacceptable toxicity

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.