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TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer (TPEIAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi Luo, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier:
NCT00940069
First received: July 14, 2009
Last updated: February 19, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Non-small-cell Lung Cancer
Adenocarcinoma
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment

Resource links provided by NLM:


Further study details as provided by Hunan Province Tumor Hospital:

Primary Outcome Measures:
  • time to progress [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: January 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TS high expression genotype
TS high expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
Drug: pemetrexed

'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.

'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.

Other Name: Alimta
Experimental: TS low expression genotype
TS low expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
Drug: pemetrexed

'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.

'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.

Other Name: Alimta

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(thymidylate synthase) 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(white blood cell)of all patients.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00940069

Locations
China, Hunan
HuNan province tumor hospital
ChangSha, Hunan, China, 410013
Sponsors and Collaborators
Hunan Province Tumor Hospital
Investigators
Study Chair: Yi Luo, doctor Hunan Province Tumor Hospital
Principal Investigator: Nong Yang, doctor Hunan Province Tumor Hospital
  More Information

Publications:
Responsible Party: Yi Luo, director, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT00940069     History of Changes
Other Study ID Numbers: LYN-LC-001 
Study First Received: July 14, 2009
Last Updated: February 19, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hunan Province Tumor Hospital:
TS
polymorphism
lung cancer
adenocarcinoma
pemetrexed

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016