An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in mCRC

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. Identifier: NCT01039506
Recruitment Status : Unknown
Verified March 2013 by Daiichi Sankyo Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : December 25, 2009
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
Daiichi Sankyo Co., Ltd.

Brief Summary:
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Drug: CPT-11 based regimens

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
Study Start Date : October 2009
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
UGT1A1 genotpyed patients Drug: CPT-11 based regimens

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: every two or three months ]

Secondary Outcome Measures :
  1. Overall survival, Time to treatment failure, response rate, disease control rate, safety [ Time Frame: adverse events will be collected during treatment ]

Biospecimen Retention:   Samples With DNA
white cells

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan

Inclusion Criteria:

  • Metastatic colorectal cancer (adenocarcinoma)
  • UGT1A1 genotyped patients
  • Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion Criteria:

  • Contraindication of CPT-11
  • ECOG PS 3-4
  • Patients to receiving CPT-11 as adjuvant chemotherapy
  • History of pelvic irradiation

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 identifier (NCT number): NCT01039506

Department of Clinical Oncology, National Defense Medical College Hospital
Tokorozawa, Saitama, Japan, 359-8513
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Principal Investigator: Wataru Ichikawa, MD. PhD. Department of Clinical Oncology, National Defense Medical College

Responsible Party: Daiichi Sankyo Co., Ltd. Identifier: NCT01039506     History of Changes
Other Study ID Numbers: TOP009-061
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Daiichi Sankyo Co., Ltd.:
UGT1A1, irinotecan

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