A phase II study of a short bevacizumab infusion in patients with metastatic colorectal cancer.

UMIN ID: UMIN000025748

Registered date:03/04/2017

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: unresectable metastatic/recurrent colorectal cancer
• Date of first enrollment: 2017/04/10
• Target sample size: 55
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Bevacizumab was given over 30 min at the first time. If patients had no infusion reaction,the time was shortend to 10 min

Outcome(s)

• Primary Outcome: Progression free survival The rate of infusion reaction
• Secondary Outcome: The rate of infusion reaction The rate of bevacizumab-induced proteinuria and hypertension

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Serious complication (interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension) 2) Symptomatic or asymptomatic but treated heart disease 3) Active infection. 4) History of serious drug hypersensitivity or a history of drug allergy 5) Brain metastasis 6) Patients with perforated disease 7) Patients with thrombosis 8) Hemorrhagic diathesis, coagulation disorder 9) Pregnant or lactating woman 10) Not appropriate for the study at the physician's assessment

Related Information

• Primary Sponsor: Dept of Gastroenterology Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: Dept of Gastroenterology Osaka City University Graduate School of Medicine