- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401192
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
July 22, 2011 updated by: Samsung Medical Center
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
304
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Contact:
- Myung-Ju Ahn, M.D., Ph.D.
-
Sub-Investigator:
- Jong-Mu Sun, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TS positive cohort & Gem/Cis Tx arm
Among TS expression positive patients, some will be randomized to Gem/cis therapy
|
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
|
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
pemetrexed 500mg/m2 & cisplatin 70mg/m2 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
|
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
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
|
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate
Time Frame: 12 months
|
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
|
12 months
|
response rate
Time Frame: 12 months
|
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Myung-Ju Ahn, M.D., Ph.D., Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 22, 2011
First Posted (Estimate)
July 25, 2011
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Folic Acid Antagonists
- Gemcitabine
- Cisplatin
- Pemetrexed
Other Study ID Numbers
- 2011-06-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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