Irinotecan in Treating Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003544|
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : June 26, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with metastatic colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: irinotecan hydrochloride Procedure: surgical procedure||Phase 2|
OBJECTIVES: I. Evaluate the clinical usefulness of preoperative irinotecan in patients with high risk, technically resectable metastatic colorectal cancer that is refractory to fluorouracil. II. Evaluate prospectively the relationship between expression of selected molecular determinants of response and clinical responsiveness to irinotecan in these patients. III. Determine the effect of treatment with irinotecan on the expression of putative response determinants in these patients.
OUTLINE: This is an open label study. Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks. Course repeats every 6 weeks. After 2 courses, CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery. Approximately 4-8 weeks after surgical resection, patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4.
PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||March 2001|
|Actual Study Completion Date :||March 2001|
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): NCT00003544
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Leonard B. Saltz, MD||Memorial Sloan Kettering Cancer Center|