Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
- Efficacy as defined in RECIST criteria [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
- 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.
- 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.
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Perigueux, France, 24004|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Senlis, France, 60309|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Investigator:||Frederic Viret, MD||Institut Paoli-Calmettes|