Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC

• Conditions: Colorectal Cancer

• Registration Number: NCT01282658
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.

Detailed Description

collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Histologically confirmed colorectal cancer
2. ≥ 18 years old
3. Measurable disease, defined as to RECIST criteria
4. Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation
5. FOLFIRI±cetuximab/bevacizumab as the first-line therapy
6. Without expected course of radiotherapy during the first-line chemotherapy
7. No previous CPT-11 chemotherapy
8. ECOG performance status (PS) 0-2
9. Not pregnant or nursing and Negative pregnancy test
10. Voluntarily signed the informed consent
11. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
12. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
13. Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN

Exclusion Criteria

1. Brain metastases with obvious symptoms
2. Severe bone marrow failure and can not be corrected
3. Chronic diarrhea history
4. Bowel obstruction without control
5. Mental illness without control
6. Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension
7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
8. Pelvic radiotherapy for the past 1 year
9. Known allergy to any of the components of the study medications
10. Serious, nonhealing wound or ulcer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology; 🇨🇳 Wu han, Hubei, China