Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: capecitabine; Drug: oxaliplatin

• Registration Number: NCT00104689
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2003-06-30
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2007-03-31
• Study Completion: 2008-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine + Oxaliplatin	capecitabine	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
Capecitabine + Oxaliplatin	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

Primary Outcome Measures

Name	Time	Method
Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale

Secondary Outcome Measures

Name	Time	Method
Efficacy as defined in RECIST criteria
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
Toxicity
Pharmacokinetics

Trial Locations

Locations (9)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Institut Jean Godinot; 🇫🇷 Reims, France

Polyclinique Francheville; 🇫🇷 Perigueux, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

C.H. Senlis; 🇫🇷 Senlis, France