Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00303745|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 17, 2006
Last Update Posted : July 24, 2008
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: irinotecan hydrochloride||Phase 2|
- Compare the objective response or stable disease rate in elderly patients with unresectable, progressive, metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0 or 1 vs 2), number of associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 12 weeks thereafter.
After completion of study therapy, patients are followed every 12 weeks.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer|
|Study Start Date :||June 2006|
- Objective response
- Stable disease rate
- Quality of life
- Progression-free and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303745
|OverallOfficial:||Emmanuel Mitry, MD, PhD||Hopital Ambroise Pare|
|Study Chair:||Thomas Aparicio||Hopital Bichat - Claude Bernard|