phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Phase 2

• Conditions: lung adenocarcinoma

• Registration Number: JPRN-C000000136
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified