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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Samsung Medical Center.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01401192

First Posted: July 25, 2011

Last Update Posted: July 25, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Samsung Medical Center

Purpose

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

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Gemcitabine plus cisplatin Drug: pemetrexed plus cisplatin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	304
Study Start Date:	July 2011
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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 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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401192

Contacts


Contact: Myung-Ju Ahn, Pf	822-3410-3459	silkahn@skku.edu

Locations


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

Sponsors and Collaborators

Samsung Medical Center

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.


Responsible Party:	Myung-Ju Ahn, M.D., Ph.D., Samsung medical center
ClinicalTrials.gov Identifier:	NCT01401192 History of Changes
Other Study ID Numbers:	2011-06-006
First Submitted:	July 21, 2011
First Posted:	July 25, 2011
Last Update Posted:	July 25, 2011
Last Verified:	July 2011

Keywords provided by Samsung Medical Center:


thymidylate synthase

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Pemetrexed	Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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