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NCT01040312 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01040312
Other study ID # TOP009-062
Secondary ID 090946
Status Completed
Phase
First received
Last updated
Start date October 15, 2009
Est. completion date September 2, 2015

Study information
Verified date May 2019
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 321
Est. completion date September 2, 2015
Est. primary completion date September 29, 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CPT-11
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 analogues
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.

Locations
Country Name City State
Japan Department of Obstetrics and Gynecology, National Defense Medical College Hospital Tokorozawa

Sponsors (1)
Lead Sponsor Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues within 6 months
Secondary Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues within 6 months
Secondary Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype within 6 months
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