Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

NCT ID: NCT00104689

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2008-01-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine + Oxaliplatin

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

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Interventions

capecitabine

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Viret, MD

Role:

Institut Paoli-Calmettes

Locations

Centre Regional Francois Baclesse

Caen, , France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

Hopital Europeen Georges Pompidou

Paris, , France

Polyclinique Francheville

Périgueux, , France

Institut Jean Godinot

Reims, , France

Centre Rene Huguenin

Saint-Cloud, , France

C.H. Senlis

Senlis, , France

Institut Claudius Regaud

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

Viret F, Bugat R, Ducreux M, et al.: XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study. [Abstract] J Clin Oncol 25 (Suppl 18): A-19513, 708s, 2007.

Reference Type: RESULT

Other Identifiers

FRE-FNCLCC-GERICO-02/0301

Identifier Type: -

Identifier Source: secondary_id

EU-20500

Identifier Type: -

Identifier Source: secondary_id

CDR0000416120

Identifier Type: -

Identifier Source: org_study_id