Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104689
• Other study ID #: CDR0000416120
• Secondary ID: FRE-FNCLCC-GERIC
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2003
• Est. completion date: January 2008

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2008
• Est. primary completion date: March 31, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• capecitabine

• oxaliplatin

Locations

Country	Name	City	State
France	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	Perigueux
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

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale
Secondary	Toxicity
Secondary	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
Secondary	Efficacy as defined in RECIST criteria
Secondary	Pharmacokinetics