Previously treated non-small cell lung cancer
Conditions
Interventions
A: Experimental arm Erlotinib monotherapy
B: Reference arm Docetaxel monotherapy
Sponsors
National Hospital Organization Headquarters Center for Support and Education of Clinical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with non-small cell lung cancer of stage IIIB or IV, which was pathologically proven and who are not candidates for radiotherapy with a curative intent. 2)Patients who heve previously treated one or two chemotherapy. *Prior chemotherapy consisting of platinum agents in at least one regimen. *Adjuvant chemotherapy, consisting of platinum agent, is considered as one regimen of chemotherapy. 3)No prior drug therapy targeting EGFR-TKIs. 4)No prior chemotherapy, consisting of docetaxel. 5)Patients with evaluable or measurable ( by CT or MRI) disease. 6)Age eligible for study: 20 years and above 7)ECOG PS 0-2 8)Sufficient organ function WBC>=3,500/mm3 Hb>=9.0g/dl Plt >=100,000/mm3 Neutrophil>=1,500/mm3 GOT/GPT <=100IU/L T-bil=<1.5mg/dl Cr. =<1.5mg/dL SpO2>=92% 9)Patients are expected to live over 12 weeks. 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of obvious distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT (Patients with radiation peumonitis limited to radiation field are eligible) 2)History of obvious drug induced interstitial pneumonia or pneumoconiosis 3)History of symptomatic brain metastases. Patients with brain metastases are eligible, if thier brain metastases are controlled by radiotherapy or drug therapy. 5)History of severe drug allergy 6)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 7)History of active infection or other serious disease condition (poorly controlled diabetes mellitus, poorly controlled cardiac disease, GI bleeding, cirrhosis, ileus, persistant watery diarrhea, etc) 8)History of active double cancer 9)History of active psychological disease. 10) History of pregnancy or lactation 11) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,response, safety, and analysis of EGFR mutation using tumor sumples | — |
Countries
Japan
Contacts
Public ContactKazuhiro Asami
National Hospital Organization Kinki-chuo Chest Medical Center Internal Medicine
Outcome results
None listed