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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01282658
Recruitment Status : Unknown
Verified November 2010 by Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : January 25, 2011
Last Update Posted : February 17, 2011
Wuhan Union Hospital, China
Wuhan University
Information provided by:
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.

Condition or disease
Colorectal Cancer

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

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC
Study Start Date : November 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Colorectal cancer

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282658

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

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
Principal Investigator: Yuan X Lin, PHD Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology

A Report of Cancer Incidence and Mortality from 34 Cancer Registries in China,2006. China Cancer 19:356-65, 2010

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
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: November 2010

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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action