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

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

Tracking Information

• First Submitted Date: August 4, 2010
• First Posted Date: September 1, 2010
• Last Update Posted Date: September 3, 2010
• Study Start Date: December 2009
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2010): response rate [ Time Frame: six weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Toxicity
• Non-small Cell Lung Cancer

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 31, 2010): 68
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01192243
• Other Study ID Numbers: Iressa combined with Pem/Cis
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
• Study Sponsor: Fudan University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jianhua Chang, MD,PhD; Fudan University affiliated cancer hospital

• PRS Account: Fudan University
• Verification Date: September 2010