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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wuhan Union Hospital, China
Wuhan University
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01282658
First received: January 24, 2011
Last updated: February 16, 2011
Last verified: November 2010
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colorectal cancer

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282658

Contacts
Contact: Yuan X Lin, PHD 0086-02783663342 yxl@medmail.com.cn
Contact: huang liu, MD 0086-02783663514 huangliu017@163.com

Locations
China, Hubei
Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology Recruiting
Wu han, Hubei, China, 430030
Contact: Yuan x lin, PHD    0086-02783663342    yxl@medmail.com.cn   
Contact: Huang liu, MD    0086-02783663514    huangliu017@163.com   
Sub-Investigator: Xie C hua, PHD         
Sub-Investigator: Zhang Tao         
Sponsors and Collaborators
Huazhong University of Science and Technology
Wuhan Union Hospital, China
Wuhan University
Investigators
Principal Investigator: Yuan X Lin, PHD Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yuan Xianglin, Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology
ClinicalTrials.gov Identifier: NCT01282658     History of Changes
Other Study ID Numbers: TJCC-001
Study First Received: January 24, 2011
Last Updated: February 16, 2011
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
CPT-11,pharmacogenomics,colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 29, 2014