A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

UMIN ID: C000000072

Registered date:22/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: previously untreated elderly non-small cell lung cancer
• Date of first enrollment: 2005/06/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 1, and gemcitabine with 100 ml of normal saline, given intravenously over 30 minutes before the administration of carboplatin infusion on days 1 and 8, every 3 weeks.

Outcome(s)

• Primary Outcome: to establish MTD and to determine the RD

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.

Related Information

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