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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

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE September 1, 2010
Last Update Posted Date September 3, 2010
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
response rate [ Time Frame: six weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
  • Number of Participants with Adverse Events [ Time Frame: six weeks ]
    according to NCI CTC V3.0
  • Progression free survival [ Time Frame: six weeks ]
  • quality of life [ Time Frame: six weeks ]
    according to FACT-LCS scores
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
  • adverse event [ Time Frame: six weeks ]
    according to NCI CTC V3.0
  • Progression free survival [ Time Frame: six weeks ]
    according to NCI CTC V3.0
  • quality of life [ Time Frame: six weeks ]
    according to FACT-LCS scores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Official Title  ICMJE Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Toxicity
  • Non-small Cell Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2010)
68
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01192243
Other Study ID Numbers  ICMJE Iressa combined with Pem/Cis
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
PRS Account Fudan University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP