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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hunan Province Tumor Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier:
NCT00940069
First received: July 14, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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
Advanced Lung Cancer
Chemotherapy
 Drug: pemetrexed,cisplatin
 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TS high expression genotype
TS high expression genotype advanced lung adenocarcinoma, delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
 Drug: pemetrexed,cisplatin
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 advanced lung adenocarcinoma, delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
 Drug: pemetrexed,cisplatin
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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940069

Contacts
Contact: Nong Yang 0086-731-13055193557 yangnong0217@sina.com
Contact: Yi Luo 0086-731-88651593 luoyi702@sina.com

Locations
China, Hunan
HuNan province tumor hospital Recruiting
ChangSha, Hunan, China, 410013
Contact: Nong Yang, doctor     0086-731-13055193557     yangnong0217@sina.com    
Contact: Yi Luo, doctor     0086-731-88651593     luoyi702@163.com    
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

No publications provided

Responsible Party: Prof YiLuo, Associate Prof NongYang, 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: July 14, 2009
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
 Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 21, 2013