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

July 21, 2011
July 22, 2011
July 2011
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01401192 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
304
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Myung-Ju Ahn, Pf 822-3410-3459 silkahn@skku.edu
Korea, Republic of
 
NCT01401192
2011-06-006
No
Myung-Ju Ahn, M.D., Ph.D., Samsung medical center
Samsung Medical Center
Not Provided
Principal Investigator: Myung-Ju Ahn, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
July 2011

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