Irinotecan in Treating Asian Patients With Solid Tumors
Recruitment status was Recruiting
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
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study to Investigate Genotype-Based Dose Individualization in Asian Cancer Patients|
- Dose-limiting toxicity [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Time to tumor response [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
- 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.
|National Cancer Centre - Singapore||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Donald Poon, MD 65-6-436-8000|
|Principal Investigator:||Donald Poon, MD||National Cancer Centre, Singapore|
|Principal Investigator:||Balram Chowbay, MD||National Cancer Centre, Singapore|