Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

UMIN ID: C000000084

Registered date:01/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small-cell lung carcinoma
• Date of first enrollment: 2001/10/01
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy CPT-11 (60 mg/m2, weekly) CDDP (25 mg/mg2, weekly) at leaset 6 courses

Outcome(s)

• Primary Outcome: Response rate (6 weeks interval for confirming SD)
• Secondary Outcome: Toxicity Survival

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Prior chemotherapy including irinotecan 2) Prior chemotherapy by 2 or more chemotherapeutic regimens 3) Prior resection 4) Requirement of thoracic irradiation 5) Any contraindication for irinotecan, such as interstitial pneumonitis 6) Pleural effusion/ascites requiring treatment 7) Pericardial effusion 8) Serious concomitant medical conditions, including uncontrolled diabetes mellitus, angina pectoris, myocardial infarction within 3 months, and others 9) Brain metastasis requiring treatment 10) Concomitant malignancy 11) History of serious drug allergy 12) Pregnancy, potential pregnancy, or breast feeding 13) Others

Related Information

• Primary Sponsor: Chiba Lung Cancer Study Group
• Source(s) of Monetary Support: Chiba Lung Cancer Study Group