Colorectal Cancer
Conditions
Keywords
CPT-11,pharmacogenomics,colorectal cancer
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.
Interventions
None listed
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan University
Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Countries
China
Contacts
Primary ContactYuan X Lin, PHD
Backup Contacthuang liu, MD
Outcome results
None listed