Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
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 who have metastatic or recurrent colorectal cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CWRU 1296: Biochemical and Pharmacokinetic Predictors of Colon Cancer Response to a Topoisomerase I Directed Treatment With Irinotecan|
- Effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer. [ Time Frame: Starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. ] [ Designated as safety issue: No ]
|Study Start Date:||September 1996|
|Study Completion Date:||January 2001|
|Primary Completion Date:||July 2000 (Final data collection date for primary outcome measure)|
Drug: irinotecan hydrochloride
OBJECTIVES: I. Confirm the greater than 20% response rate to irinotecan in patients with metastatic or recurrent colorectal cancer who have not receive prior chemotherapy for their advanced disease. II. Characterize pharmacokinetic parameters of irinotecan and its metabolite SN-38 and their relationship to response and toxic effect. III. Characterize tumor samples for topoisomerase I activity, proliferative fraction (ki67 expression), and p53 expression and determine whether clinical response is related to these tumor characteristics in patient population. IV. Determine the in vitro inhibition of topoisomerase I activity by irinotecan, SN-38, and other camptothecin analogs and evaluate whether the degree of in vitro sensitivity to irinotecan and/or SN-38 is associated with clinical response in these patients. VII. Determine the frequency of somatic mutations following irinotecan and correlate this with pharmacologic parameters.
OUTLINE: Patients receive irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a complete response may receive additional courses of treatment. Patients are followed until death.
PROJECTED ACCRUAL: A total of 54 patients will be accrued into this study at a rate of 25 patients per year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002933
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Veterans Affairs Medical Center - Cleveland|
|Cleveland, Ohio, United States, 44106|
|Study Chair:||James KV Willson, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|