Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

July 22, 2011 updated by: Samsung Medical Center

A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

304

Phase

  • Phase 2

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Myung-Ju Ahn, M.D., Ph.D.
        • Sub-Investigator:
          • Jong-Mu Sun, M.D., Ph.D.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed nonsquamous NSCLC
  • Stage IIIb, IV or recurrent NSCLC
  • Age ≥ 18years
  • ECOG performance status of 0 to 1
  • Known TS immunohistochemical analysis data
  • At least one measurable lesion by RECIST 1.1
  • No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
  • Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
  • At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
  • Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

  • Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
  • Patients with post-obstructive pneumonia or uncontrolled serious infection

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TS positive cohort & Gem/Cis Tx arm
Among TS expression positive patients, some will be randomized to Gem/cis therapy
Drug: Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
Active Comparator: TS+ cohort & Pem/Cis arm
Among patients with TS+, randomised to Pem/cis chemotherapy
Drug: pemetrexed plus cisplatin
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
Drug: pemetrexed plus cisplatin
pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks
Active Comparator: TS negative cohort & Pem/Cis Tx arm
Among patients with TS-, some will be randomised to Pem/cis Tx arm
Drug: pemetrexed plus cisplatin
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
Drug: pemetrexed plus cisplatin
pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks
Experimental: TS negative cohort & Gem/Cis Tx arm
Among patients with TS-, some will be randomised to Gem/Cis Tx arm
Drug: Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive value of TS expression
Time Frame: 12 months
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 12 months
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
12 months
response rate
Time Frame: 12 months
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients
12 months

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Myung-Ju Ahn, M.D., Ph.D., Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-06-006

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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