Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Brief 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.
Detailed 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.
Interventions
DRUGcapecitabine
DRUGoxaliplatin
Sponsors
UNICANCER
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale | — |
Secondary
| Measure | 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 | — |
Countries
France
Outcome results
None listed