Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Phase 2
- Conditions
- ToxicityNon-small Cell Lung Cancer
- Registration Number
- NCT01192243
- Lead Sponsor
- Fudan University
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method response rate six weeks
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events six weeks according to NCI CTC V3.0
Progression free survival six weeks quality of life six weeks according to FACT-LCS scores
Trial Locations
- Locations (1)
Cancer hospital Fudan University
🇨🇳Shanghai, Shanghai, China