Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study

UMIN ID: UMIN000001733

Registered date:26/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 2005/07/01
• Target sample size: 16
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CDDP 60 mg/m2 day-1 (0.5-h infusion) CPT-11 30 to 60 mg/m2 day-1, 8, 15 (1.5-h infusion) HD was started immediately after completing the administration of CPT-11, and the chemotherapy was repeated every 4 weeks. The dose of CPT-11 was escalated by 10mg/m2 increment course-by-course within every patient.

Outcome(s)

• Primary Outcome: To analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD.
• Secondary Outcome: To evaluate feasibility and toxicity.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients with other concurrent malignancies, active infections, pulmonary fibrosis, uncontrolled massive pleural effusion or ascites, significant cardiovascular diseases, or symptomatic metastasis to the brain, pregnancy or breast-feeding were excluded.

Related Information

• Primary Sponsor: Niigata Lung Cancer Treatment Group
• Source(s) of Monetary Support: Niigata Lung Cancer Treatment Group