JPRN-C000000136
Completed
Phase 2
phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- West Japan Oncology Group
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) primary lung adenocarcinoma; 2\) stage IIIB or IV disease, unsuitable for radical thoracic radiation; 3\) age of 70 years or older; 4\) Eastern Cooperative Oncology Group performance status of 0 to 2; 5\) no prior chemotherapy; 6\) measurable lesions; 7\) adequate organ fanctions; and 8\) written informed consent.
Exclusion Criteria
- •1\) interstitial pneumonitis or pulmonary fibrosis; 2\) thoracic radiation within four weeks; 3\) ongoing or planning palliative radiation; 4\) symptomatic brain metastases; 5\) uncontrolled pleural effusion; 6\) pericardial effusion requiring drainage; 7\) watery diarrhea; 8\) serious underlying disease; 9\) active concomitant malignancies; 10\) a history of serious drug allergy; 11\) clinically significant psychiatric disorder; and 12\) unsuitable for entry to the study, decided by a medical oncologist.
Outcomes
Primary Outcomes
Not specified
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