Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients

Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study ID
NCT01523431
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Injection [Camptosar] — DRUG
    CPT-11 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
  • 5-fluorouracil — DRUG
    The 5-FU dosage will remain the standard.
  • Leucovorin — DRUG
    The LV dosage will remain the standard.

Study Details

The purpose of this study is to investigate the influence of dose selection of CPT-11 on toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer patients.

Key Dates

Start date
Mar 8, 2012
Status verified
Mar 2017
Primary completion
Nov 23, 2015
Completion
Apr 27, 2016

Study Design

Enrollment
583 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard FOLFIRI for wild/hetero UGT1A1
    Irinotecan Injection \[Camptosar\] (CPT-11) 180 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.
  • Experimental: Reduced Dose of CPT-11 for homo UGT1A1
    Irinotecan Injection \[Camptosar\] (CPT-11) 90 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.
  • Active Comparator: Standard FOLFIRI for homo UGT1A1
    Irinotecan Injection \[Camptosar\] (CPT-11) 180 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.

Primary Outcome Measure

Incidence of toxicity, especially neutropenia and diarrhea [ Time Frame: From the beginning of treatment to the whole treatment period, an expected average of 6-8 months. ]

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