Irinotecan in Treating Asian Patients With Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: irinotecan hydrochloride; Other: pharmacogenomic studies; Other: pharmacological study

• Registration Number: NCT00731276
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04-03
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2015-11
• Study Completion: 2016-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Four Regimens	pharmacogenomic studies	The study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are: 1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly 2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly
Four Regimens	pharmacological study	The study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are: 1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly 2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly
Four Regimens	irinotecan hydrochloride	The study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are: 1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly 2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	No time frame defined. Trial is still recruiting.
Maximum tolerated dose	No time frame defined. Trial is still recruiting.

Secondary Outcome Measures

Name	Time	Method
Time to progression	No time frame defined. Trial is still recruiting.
Response duration	No time frame defined. Trial is still recruiting.
Time to tumor response	No time frame defined. Trial is still recruiting.
Pharmacokinetics	No time frame defined. Trial is still recruiting.

Trial Locations

Locations (1)

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore