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

This study is currently recruiting participants.

Verified July 2011 by Samsung Medical Center

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01401192

First received: July 21, 2011

Last updated: July 22, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2011

Last Updated Date

July 22, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

predictive value of TS expression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01401192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: Gemcitabine plus cisplatin
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
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

Study Arm (s)

Experimental: TS positive cohort & Gem/Cis Tx arm
Among TS expression positive patients, some will be randomized to Gem/cis therapy

Intervention: Drug: Gemcitabine plus cisplatin
Active Comparator: TS+ cohort & Pem/Cis arm
Among patients with TS+, randomised to Pem/cis chemotherapy

Intervention: Drug: pemetrexed plus cisplatin
Active Comparator: TS negative cohort & Pem/Cis Tx arm
Among patients with TS-, some will be randomised to Pem/cis Tx arm

Intervention: Drug: pemetrexed plus cisplatin
Experimental: TS negative cohort & Gem/Cis Tx arm
Among patients with TS-, some will be randomised to Gem/Cis Tx arm

Intervention: Drug: Gemcitabine plus cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

304

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Myung-Ju Ahn, Pf

822-3410-3459

silkahn@skku.edu

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01401192

Other Study ID Numbers ^ICMJE

2011-06-006

Has Data Monitoring Committee

Responsible Party

Myung-Ju Ahn, M.D., Ph.D., Samsung medical center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Myung-Ju Ahn, M.D., Ph.D.

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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