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

The recruitment status of this study is unknown because the information has not been verified recently.

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

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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

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 ] [ 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

Secondary Outcome Measures:

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


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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
Study First Received:	July 21, 2011
Last Updated:	July 22, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:


thymidylate synthase

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 01, 2015

To Top