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

Daiichi Sankyo Co., Ltd.321 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

321

Conditions

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

Interventions

CPT-11DRUG

CPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.

Platinum analoguesDRUG

Platinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynecology, National Defense Medical College Hospital

Tokorozawa, Japan

Outcomes

Primary Outcomes

Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues

Time frame: within 6 months

Secondary Outcomes

Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues

Time frame: within 6 months

Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype

Time frame: within 6 months

Data from ClinicalTrials.gov

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