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

Completed

• Conditions: Cervical Cancer; Non-small Cell Lung Cancer; Ovarian Cancer; Gastric Cancer (Inoperable and Recurrent); Small Cell Lung Cancer
• Interventions: Drug: CPT-11; Drug: Platinum analogues

• Registration Number: NCT01040312
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-15
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-29
• Primary Completion: 2014-09-29
• Study Completion: 2015-09-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

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

Exclusion Criteria

• Has contraindication for CPT-11
• Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UGT1A1 genotyped patients	Platinum analogues	UGT1A1 genotyped patients receive CPT-11 with platinum analogues
UGT1A1 genotyped patients	CPT-11	UGT1A1 genotyped patients receive CPT-11 with platinum analogues

Primary Outcome Measures

Name	Time	Method
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues	within 6 months

Secondary Outcome Measures

Name	Time	Method
Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues	within 6 months
Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype	within 6 months

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, National Defense Medical College Hospital; 🇯🇵 Tokorozawa, Japan