Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine + Oxaliplatin<br>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 | Drug: capecitabine<br> <br> Drug: oxaliplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| 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 |  |  | 
| Efficacy as defined in RECIST criteria |  |  | 
| Pharmacokinetics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum