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Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT01192243
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : September 1, 2010
Last Update Posted : September 3, 2010
Sponsor:
Information provided by:
Fudan University

Study Description
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Brief Summary:
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Toxicity Non-small Cell Lung Cancer Drug: Gefitinib Drug: Pemetrexed Drug: Cisplatin or carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
Study Start Date : December 2009
Estimated Primary Completion Date : December 2011

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Arms and Interventions
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Intervention Details:
  • Drug: Gefitinib
    250mg qd po d3-16
  • Drug: Pemetrexed
    500mg/m2 venous infusion,D1,q3w
  • Drug: Cisplatin or carboplatin
    Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

Outcome Measures
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Primary Outcome Measures :
  1. response rate [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: six weeks ]
    according to NCI CTC V3.0

  2. Progression free survival [ Time Frame: six weeks ]
  3. quality of life [ Time Frame: six weeks ]
    according to FACT-LCS scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Age from 18 to 70 years old
  • At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
  • ECOG 0-1
  • Expected life time longer than 12 weeks
  • Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion Criteria:

  • Patients have not used drugs according to protocol
  • Patients were allergic to pemetrexed or cisplatin
  • Patients received radiotherapy or other biological treatment 4 weeks before the trial
  • Uncontrolled hydrothorax or hydropericardium
  • neuropathy toxicity ≥ CTC 3
  • Severe symptomatic heart disease
  • Active upper gastrointestinal ulcer or digestive disfunction
  • Severe infection or metabolic disfunction
  • Patients with other malignant tumor
  • Uncontrolled brain metastases
  • Patients have accepted other clinical trials
  • Female patients during their pregnant and lactation period, or patients without contraception
Contacts and Locations
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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): NCT01192243


Contacts
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Contact: Jianhua chang, MD,PHD 13916619284 changjianhua@hotmail.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianhua Chang, MD,PhD    13916619284    changjianhua@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
More Information
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Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT01192243    
Other Study ID Numbers: Iressa combined with Pem/Cis
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 3, 2010
Last Verified: September 2010
Keywords provided by Fudan University:
Objective response rate
Time to Progression
Quality of Live
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Cisplatin
Carboplatin
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors