Irinotecan in Treating Asian Patients With Solid Tumors

Sponsor
National Cancer Centre, Singapore
Study ID
NCT00731276
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
21 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 3, 2008
Status verified
Mar 2017
Primary completion
Nov 30, 2015
Completion
Apr 30, 2016

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Four Regimens
    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 Measure

Dose-limiting toxicity [ Time Frame: No time frame defined. Trial is still recruiting. ]

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