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.

Condition	Treatment or Intervention	Phase
stage IV colon cancer Stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum	Drug: capecitabine  Drug: oxaliplatin  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  70 Years and above,  Genders Eligible for Study:  Both

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

France
      Centre Regional Francois Baclesse, Caen,  14076,  France; Recruiting
      Centre Rene Huguenin, Saint Cloud,  92210,  France; Recruiting
      Hopital Europeen Georges Pompidou, Paris,  75015,  France; Recruiting
      Institut Claudius Regaud, Toulouse,  31052,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France; Recruiting
      Institut Jean Godinot, Reims,  51056,  France; Recruiting
      Polyclinique Francheville, Perigueux,  24004,  France; Recruiting

Study chairs or principal investigators

Frederic Viret, MD,  Institut J. Paoli and I. Calmettes   

Study ID Numbers:  CDR0000416120; FRE-FNCLCC-GERICO-02/0301; EU-20500; NCT00104689
Record last reviewed:  February 2005
Last Updated:  March 28, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00104689
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08