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An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01040312
Recruitment Status : Unknown
Verified March 2013 by Daiichi Sankyo Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2009
Last Update Posted : March 29, 2013
Sponsor:
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 safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.

Condition or disease Intervention/treatment
Small Cell Lung Cancer Non-small Cell Lung Cancer Cervical Cancer Ovarian Cancer Gastric Cancer (Inoperable and Recurrent) Drug: CPT-11 and platinum analogues

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
Study Start Date : October 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2014


Group/Cohort Intervention/treatment
UGT1A1 genotpyed patients Drug: CPT-11 and platinum analogues
platinum analogues (cisplatin, carboplatin and nedaplatin)



Primary Outcome Measures :
  1. Influence of UGT1A1 genotypes on severe toxicities (ex. neutropenia) induced by CPT-11 based regimens [ Time Frame: 3 or 6 months ]

Secondary Outcome Measures :
  1. Influence of UGT1A1 genotypes on response rate or disease control rate [ Time Frame: 3 or 6 monhs ]
  2. Exploratory analysis of risk factors for severe toxicities (ex. neutropenia) induced by CPT-11 based regimens other than UGT1A1 polymorphisms. [ Time Frame: 3 or 6 months ]

Biospecimen Retention:   Samples With DNA
white cells


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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 small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice in Japan
Criteria

Inclusion Criteria:

  • Small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer
  • Patients with UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
  • Patients to receiving CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)

Exclusion Criteria:

  • Contraindication of CPT-11
  • ECOG PS 3-4

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): NCT01040312


Locations
Japan
Department of Obstetrics and Gynecology, National Defense Medical College Hospital
Tokorozawa, Saitama, Japan, 359-8513
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Masashi Takano, MD. PhD. Department of Obstetrics and Gynecology, National Defense Medical College

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01040312     History of Changes
Other Study ID Numbers: TOP009-062
First Posted: December 29, 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Uterine Cervical Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors