Previously treated lung adeno carcinoma
Conditions
Interventions
A: Reference arm Erlotinib monotherapy
B: Experimental arm Gefitinib monotherapy
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with lung cancer which was pathologically proven adenocarcinoma. 2)Patients with stage IIIb or IV who heve previously treated one or more chemotherapy. *Adjuvant and neo-adjuvant chemotherapy are not considered as one regimen of chemotherapy. *Oral agents except for TS-1 are not considered as one regimen of chemotherapy. 3).Patients with evaluable disease (not necessarily to be measurable) 4)7.Age eligible for study: 20 years and above 5)ECOG PS 0-2 6)Sufficient organ function WBC>=3000/mm3 Plt >=75000/mm3 GOT/GPT <=100IU/L T-bil=<1.5mg/dl Cr. =<1.2mg/dL SpO2>=95% or PaO2>=60% 7)No prior drug therapy targeting EGFR (TKI, Abs) . 8)Patients are expected to live over 12 weeks. 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.) 5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage 6)History of active infection 7)History of persistent watery diarrhea 8)History of ileus 9)Patients who are not take in drug orally 10)History of symptomatic brain metastases. 11)History of active double cancer 12)History of poorly controlled cardiac diseases. 13)History of active psychological disease. 14) History of pregnancy or lactation 15) 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 rate, disease control rate, Toxicity, Time to treatment failure, | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed