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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01040312
First received: December 23, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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 Intervention
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Co., Ltd.:

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

Secondary Outcome Measures:
  • Influence of UGT1A1 genotypes on response rate or disease control rate [ Time Frame: 3 or 6 monhs ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

white cells


Estimated Enrollment: 1000
Study Start Date: October 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UGT1A1 genotpyed patients Drug: CPT-11 and platinum analogues
platinum analogues (cisplatin, carboplatin and nedaplatin)

  Eligibility

Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01040312     History of Changes
Other Study ID Numbers: TOP009-062
Study First Received: December 23, 2009
Last Updated: March 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Ovarian Neoplasms
Small Cell Lung Carcinoma
Stomach Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Lung Diseases
Neoplasms
Neoplasms by Site
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomach Diseases
Thoracic Neoplasms
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014