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

May 21, 2019 updated by: Daiichi Sankyo Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

321

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokorozawa, Japan, 359-8513
        • Department of Obstetrics and Gynecology, National Defense Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in Japan with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 with platinum analogues
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.
Other Names:
  • Camptosar
  • Topotecin
Drug: 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.
Other Names:
  • Cisplatin
  • Carboplatin
  • Nedaplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
Time Frame: within 6 months
within 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues
Time Frame: within 6 months
within 6 months
Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype
Time Frame: within 6 months
within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2009

Primary Completion (ACTUAL)

September 29, 2014

Study Completion (ACTUAL)

September 2, 2015

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (ESTIMATE)

December 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOP009-062
  • 090946 (OTHER: JAPIC ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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