We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00940069
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Adenocarcinoma Drug: pemetrexed Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2009
Primary Completion Date : June 2013
Study Completion Date : January 2015


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. time to progress [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yi Luo, 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