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

UMIN ID: C000000136

Registered date:08/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: lung adenocarcinoma
• Date of first enrollment: 2004/12/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive oral 250-mg gefitinib daily until disease progression.

Outcome(s)

• Primary Outcome: Primary endpoint: response rate. Secondary endpoints: disease control rate, overall survival, time to progression, and toxicity.

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Include 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.
• Exclude 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.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None