malignant pleural effusion caused by advanced non-small cell lung cancer
Conditions
Interventions
2:administer carboplatin/paclitaxel intravenously
1:administer gefitinib orally
Sponsors
Department of Respiratory Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients provided written informed consent; 2. Male or female,18 years of age or older; 3. Cytologically confirmed stage IIIB or IV non-small-cell lung cancer(NSCLC); 4. Malignant pleural effusion caused by NSCLC, not suitable for local chemotherapy; 5. No previous chemotherapy or biologic(include target therapy) or immunologic therapy; 6. Previous surgery and irradiation permitted if treatment completed > 6 months previously; 7. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria; 8. World Health Organization performance status 0 to 2.
Exclusion criteria
Exclusion criteria: 1. Serious allergic to gefitinib or its excipient; 2. Serious allergic to paclitaxel/ carboplatin or their excipients; 3. Serious allergic to the pretreatment drugs of chemotherapy; 4. Brain metastasis definitely or doubtingly; 5. Received gefitinib or paclitaxel/ carboplatin treatment previously; 6. Got interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis needed corticosteroids previously or any evidence of clinically active interstitial lung disease; 7. Any unresolved chronic toxicity grade > 2 by the National Cancer Institute Common Toxicity Criteria for Adverse Events from previous antitumour treatment; 8. Absolute neutrophil counts 1.5 times the upper limit of reference range (ULRR); 10. Serum creatinine > 1.5 times the ULRR and creatinine clearance 2.5 times the ULRR; 12. Researchers consider the patient can not tolerate paclitaxel / carboplatin chemotherapy; 13. Patient with malignant pleural effusion was unable or unwilling to receive thoracocentesis or intercostal tube drainage treatment; 14. Concomitant any other antitumour treatment; 15. Use phenytoin, carbamazepine, rifampicin, phenobarbital; 16. According to researchers' judgement, any evidence of severe systemic disease bad for patient's safety or significant active infections; 17. Pegnancy or breast-feeding; 18. Participated in other clinical studies wthin three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;immunological effects; | — |
Countries
China
Contacts
Public ContactHuanZhong Shi
Outcome results
None listed