Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
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.
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.
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