Overview

This trial is active, not recruiting.

Conditions small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer, gastric cancer (inoperable and recurrent)
Treatment cpt-11 and platinum analogues
Sponsor Daiichi Sankyo Co., Ltd.
Start date October 2009
End date March 2013
Trial size 1000 participants
Trial identifier NCT01040312, TOP009-062

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
cpt-11 and platinum analogues
platinum analogues (cisplatin, carboplatin and nedaplatin)

Primary Outcomes

Measure
Influence of UGT1A1 genotypes on severe toxicities (ex. neutropenia) induced by CPT-11 based regimens
time frame: 3 or 6 months

Secondary Outcomes

Measure
Influence of UGT1A1 genotypes on response rate or disease control rate
time frame: 3 or 6 monhs
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Masashi Takano, MD. PhD.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Co., Ltd..