Status:
UNKNOWN
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Lead Sponsor:
Fudan University
Conditions:
Toxicity
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01192243
Start Date
December 1 2009
Last Update
September 3 2010
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032