Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments capecitabine, oxaliplatin
Phase phase 2
Sponsor UNICANCER
Start date July 2003
Trial size 60 participants
Trial identifier NCT00104689, CDR0000416120, EU-20500, FRE-FNCLCC-GERICO-02/0301

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
time frame:

Secondary Outcomes

Measure
Toxicity
time frame:
Percentage of patients who receive the first 3 treatment courses at a lower dose and the percentage of patients who receive all 6 treatment courses at both lower and higher doses
time frame:
Efficacy as defined in RECIST criteria
time frame:
Pharmacokinetics
time frame:

Eligibility Criteria

Male or female participants at least 70 years old.

DISEASE CHARACTERISTICS: - Diagnosis of colorectal adenocarcinoma - Metastatic disease - Requires first-line therapy for metastatic disease PATIENT CHARACTERISTICS: Age - Over 70 Performance status - Katz's Activities of Daily Living scale < 6 (≤ 6 for patients ≥ 80 years of age) Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - AST and ALT < 2 times normal (5 times normal if due to hepatic metastases) - Bilirubin < 2 times normal (5 times normal if due to hepatic metastases) Renal - Creatinine clearance > 30 mL/min Other - No clinical neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior adjuvant chemotherapy - No prior chemotherapy for metastatic disease Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).