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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192243
First received: August 4, 2010
Last updated: September 2, 2010
Last verified: September 2010

August 4, 2010
September 2, 2010
December 2009
December 2011   (final data collection date for primary outcome measure)
response rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01192243 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to NCI CTC V3.0
  • Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to FACT-LCS scores
  • adverse event [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to NCI CTC V3.0
  • Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
    according to NCI CTC V3.0
  • quality of life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    according to FACT-LCS scores
Not Provided
Not Provided
 
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Toxicity
  • Non-small Cell Lung Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Jianhua chang, MD,PHD 13916619284 changjianhua@hotmail.com
China
 
NCT01192243
Iressa combined with Pem/Cis
Yes
Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
Fudan University
Not Provided
Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
Fudan University
September 2010

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