Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00002902|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : July 24, 2008
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 plus ICI D1694 in treating patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: raltitrexed||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the relationship between topoisomerase I expression in peripheral mononuclear cells and myelosuppression and/or gastrointestinal toxicity. IV. Investigate the effect of CPT-11 on thymidylate synthase expression in tumor.
OUTLINE: This is a dose-escalating study to determine the maximum tolerated dose (MTD) of ICI D1694 (TDX) given in combination with irinotecan. Irinotecan is given intravenously on day 1 and ICI D1694 intravenously on day 2. Treatment is repeated every 3 weeks until disease progression or unacceptable toxicity intervenes. Cohorts of 3-6 patients receive escalated doses of TDX until the MTD is defined; an additional 10-12 patients will be entered at the MTD to confirm this as a recommended phase II dose.
PROJECTED ACCRUAL: 30-35 patients will be entered.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE|
|Study Start Date :||April 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002902
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Peter J. O'Dwyer, MD, BCh||Abramson Cancer Center of the University of Pennsylvania|