Spots Global Cancer Trial Database for Irinotecan in Treating Asian Patients With Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Irinotecan in Treating Asian Patients With Solid Tumors

Official Title: Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients

Study ID: NCT00731276

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

irinotecan hydrochloride

pharmacogenomic studies

pharmacological study

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.

Detailed Description: OBJECTIVES: Primary * To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors. Secondary * To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G. * To evaluate time to tumor response, response duration, and time to progression in these patients. OUTLINE: Patients are stratified according to genotype status (UGT1A1\*28 vs UGT1A1\*6) Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic, and pharmacodynamic studies.