Irinotecan in Treating Asian Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00731276|
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : March 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Other: pharmacogenomic studies Other: pharmacological study||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients|
|Actual Study Start Date :||April 3, 2008|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||April 2016|
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|
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731276
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Su Pin Choo, MD||National Cancer Centre, Singapore|