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

ClinicalTrials.gov processed this record on June 17, 2013