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Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Samsung Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01401192
First received: July 21, 2011
Last updated: July 22, 2011
Last verified: July 2011
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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 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:
Genetics Home Reference related topics:
lung cancer
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 ]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 ]Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
- response rate [ Time Frame: 12 months ]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 (Adult, Senior) |
| 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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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Samsung Medical Center:
|
thymidylate synthase |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on August 16, 2017