Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Unicancer

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: oxaliplatin; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00104689

EU-20500

CDR0000416120

FRE-FNCLCC-GERICO-02/0301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 70 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Capecitabine + Oxaliplatin

Experimental group

Description:

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

Treatment:

Drug: oxaliplatin

Drug: capecitabine