NCT00731276

Irinotecan in Treating Asian Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride
OTHER	pharmacogenomic studies
OTHER	pharmacological study

Timeline

• Start date: 2008-04-03
• Primary completion: 2015-11-01
• Completion: 2016-04-01
• First posted: 2008-08-08
• Last updated: 2017-03-31

Locations

1 site across 1 country: Singapore