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

NCT01523431 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 583

Last updated 2017-03-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Irinotecan Injection [Camptosar]

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.

DRUG

5-fluorouracil

The 5-FU dosage will remain the standard.

DRUG

Leucovorin

The LV dosage will remain the standard.

Sponsors & Collaborators

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Jian-Ming Xu, M.D. · Affiliated Hospital, Academy of Military Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-08
Primary Completion
2015-11-23
Completion
2016-04-27
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523431 on ClinicalTrials.gov