A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen

UMIN ID: C000000219

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 2001/12/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The chemotherapy consisted of paclitaxel 150 mg/m2, iv, on day 1 ,and gemcitabine 1000 mg/m2, iv, on days 1 and 8. The treatment was repeated every 3 weeks.

Outcome(s)

• Primary Outcome: Response rate (according to RECIST criteria)
• Secondary Outcome: Adverse events, Survival rate, Survival time, Time to progression, Completion of the treatment

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with lesions that can not judged for response by only chemotherapy. Patients previously treated with chemoradiotherapy are not allowed to be enrolled. 2) Active infectious disease and complications that affect the trial. 3) Apparent interstitial pneumonitis or fibrosis on chest X ray. 4) Symptomatic brain metastases. 5) Patients requiring pleural/ pericardial drainage. 6) Previous chemotherapy with gemcitabine or paclitaxel. 7) Allergy for a polyoxyethylene castor oil or a hardening castor oil component drug. 8) Woman who has a possibility of pregnancy. 9) Interval less than 30days from the last day of a previous treatment. 10) Other patients unsuitable for the study.

Related Information

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