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

Daiichi Sankyo

Status: Completed

Conditions: Gastric Cancer (Inoperable and Recurrent); Small Cell Lung Cancer; Non-small Cell Lung Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: CPT-11; Drug: Platinum analogues

Study type: Observational

Funder types: Industry

Identifiers

NCT01040312

TOP009-062

090946 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

321 participants in 1 patient group

UGT1A1 genotyped patients

Description:

UGT1A1 genotyped patients receive CPT-11 with platinum analogues

Treatment:

Drug: Platinum analogues

Drug: CPT-11