Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
thymidylate synthase
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine plus cisplatin Type: Drug
Name: pemetrexed plus cisplatin Type: Drug
Name: pemetrexed plus cisplatin Type: Drug
Name: Gemcitabine plus cisplatin Type: Drug
Overall Status
Recruiting
Summary
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Myung-Ju Ahn, M.D., Ph.D.
Start Date
July 2011
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page