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

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ClinicalTrials.gov Identifier: NCT01401192
Recruitment Status : Unknown
Verified July 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:
Samsung Medical Center

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
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
Study Start Date : July 2011
Estimated Primary Completion Date : December 2013

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Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. response rate [ Time Frame: 12 months ]
    Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Contact: Myung-Ju Ahn, Pf 822-3410-3459 silkahn@skku.edu

Locations
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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
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Principal Investigator: Myung-Ju Ahn, M.D., Ph.D. Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Myung-Ju Ahn, M.D., Ph.D., Samsung medical center
ClinicalTrials.gov Identifier: NCT01401192    
Other Study ID Numbers: 2011-06-006
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by Samsung Medical Center:
thymidylate synthase
Additional relevant MeSH terms:
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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