Irinotecan and Capecitabine in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003867|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : September 10, 2018
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: capecitabine Drug: irinotecan hydrochloride||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Official Title:||Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies|
|Actual Study Start Date :||March 1999|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
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): NCT00003867
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|Study Chair:||Sridhar Mani, MD||Albert Einstein College of Medicine|