Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer

UMIN ID: UMIN000011485

Registered date:01/09/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metastatic Colorectal Cancer
• Date of first enrollment: 2013/10/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A group Panitumumab is administered intravenously in 6mg/kg by biweekly skin care+antibiotics Clarithromycin is administered orally twice a day
B group Panitumumab is administered intravenously in 6mg/kg by biweekly skin care only

Outcome(s)

• Primary Outcome: incidence rates of skin toxicity (>=Grade2) with or without antibiotics during the 6 weeks from the treatment started
• Secondary Outcome: time to the first appearance of skin toxicity (Grade>=2), incidence rates of skin toxicity(Grade>=3), response rate, disease control rate and progression free survival(each line, each chemotherapy regimen), difference between patients' and doctors' view to the side effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Previous history of chemotherapy with anti EGFR antibody 2)Contraindications to panitumumab 3)Complications or history of interstitial pneumonia, pulmonary fibrosis 4)Pregnant woman, possibly pregnant woman 5) Contraindications to clarithromycin 6)Any other cases who are not suitable for combination chemotherapy 7) Any other cases who are regarded as inadequate for study enrollment by the investigator

Related Information

• Primary Sponsor: Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
• Source(s) of Monetary Support: None