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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
National Cancer Centre - Singapore
Singapore, Singapore
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.