Phase I/II trial of CPT-11 + S-1 combination therapy for patients with previously treated non-small cell lung cancer

UMIN ID: UMIN000001960

Registered date:01/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2006/10/01
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CPT-11 is administered intravenously on day 1 and day 8 every 21 days. S-1 is administered given orally from day 1 to day 14 every 21 days.

Outcome(s)

• Primary Outcome: Anticancer efficacy
• Secondary Outcome: Duration of effect, Progression free survival, overall survival (Median survival time, 1-year survival rate), Adverse events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1) Patients with infections 2) Patients with massive pleural or pericardial effusion ,or ascites 3) Patients with pulmonary fibrosis interstitial pneumonia 4) Patients with diarrhea 5) Patients with intestinal paralysis or intestinal obstruction 6) Patients clinically important heart disease 7) Patients with significant complications 8) Patients with pregnancy or lactation 9) Patients with active concomitant malignancy 10) Patients with symptomatic brain metastasis 11) Patients in the administration of flucytosine (12) Patients in the administration of atazanavir sulfate

Related Information

• Primary Sponsor: Keio University School of Medicine Division of Pulmonary Medicine
• Source(s) of Monetary Support: Keio University School of Medicine Division of Pulmonary Medicine