Genetic Polymorphism oriented PhaseI Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer

UMIN ID: UMIN000002092

Registered date:18/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 2005/01/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients received treatment for 12 weeks. CPT-11 was administered once every two weeks in 500 ml of normal saline or dextrose via 120-min intravenous infusion on day 1, 15, 29, 43, 57 and 71. 5-DFUR was given as 200-mg capsules, two capsules were administered orally in the morning and evening after a meal on 5 consecutive days followed by a 2-day washout during the 12-week treatment period.

Outcome(s)

• Primary Outcome: Primary endpoint: MTD, DLT, recomended dose

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients were ineligible if they had any of the following conditions: serious infectious disease or other severe complications (e.g., pulmonary fibrosis/interstitial pneumonia, uncontrollable diabetes); watery diarrhea, paralytic ileus, or intestinal obstruction; massive pleural effusion or ascitic fluid; symptomatic brain metastases; active concurrent malignancies; pregnancy or lactation, or desire for pregnancy; a history of drug allergy; and prior treatment with CPT-11.

Related Information

• Primary Sponsor: Department of Digestive Surgery and Surgical Oncology (Surgery II), and Department of Oncology and Laboratory Medicine, Yamaguchi University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Oncology and Laboratory Medicine, Yamaguchi University Graduate School of Medicine