TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer
Conditions
Advanced Lung Cancer - Chemotherapy
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
TS, polymorphism, lung cancer, adenocarcinoma, pemetrexed
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: pemetrexed,cisplatin
Type: Drug
Overall Status
Recruiting
Summary
The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
Detailed Description
1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2.

2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks.

3. Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity.

4. The study was designed to evaluate TS gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.

5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC of all patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- histologic or cytologic proof of advanced lung adenocarcinoma

- primary treatment

- normal organ function

- Eastern Cooperative Oncology Group performance status 0 to 2

Exclusion Criteria:

- Symptomatic patients with brain metastases

- Major organ dysfunction and severe heart disease
Location
HuNan province tumor hospital
ChangSha, Hunan, China
Status: Recruiting
Contact: Nong Yang, doctor - 0086-731-13055193557 - yangnong0217@sina.com
Start Date
March 2009
Completion Date
December 2010
Sponsors
Hunan Province Tumor Hospital
Source
Hunan Province Tumor Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page