Irinotecan in Treating Asian Patients With Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Other: pharmacogenomic studies Other: pharmacological study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients|
- Dose-limiting toxicity [ Time Frame: No time frame defined. Trial is still recruiting. ]
- Maximum tolerated dose [ Time Frame: No time frame defined. Trial is still recruiting. ]
- Pharmacokinetics [ Time Frame: No time frame defined. Trial is still recruiting. ]
- Time to tumor response [ Time Frame: No time frame defined. Trial is still recruiting. ]
- Time to progression [ Time Frame: No time frame defined. Trial is still recruiting. ]
- Response duration [ Time Frame: No time frame defined. Trial is still recruiting. ]
|Actual Study Start Date:||April 3, 2008|
|Study Completion Date:||April 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.
Four Regimens are:
|Drug: irinotecan hydrochloride Other: pharmacogenomic studies Other: pharmacological study|
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731276
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Su Pin Choo, MD||National Cancer Centre, Singapore|