Clinical Trial: Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase I Trial of Intraperitoneal Bevacizumab in Refractory Malignant Ascites.

Brief Summary: Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.

Detailed Summary:
Sponsor: Peking University

Current Primary Outcome:

• adverse events [ Time Frame: during the treatment in the hospital,an expected average of 1 week ]
  participants will be followed for the duration of hospital stay, an expected average of 1 week
• Maximum tolerated dose [ Time Frame: 1 week ]
  during the treatment in the hosptital

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Objective response rate [ Time Frame: 1 week ]
  ultrasound will be performed every week for efficacy evaluation
• time to treatment failure(TTF) [ Time Frame: 1 month ]
  the follow-up visit of time to TTF will be performed every 4 weeks
• time to death(TTD) [ Time Frame: 2 months ]
  TTD means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost

Original Secondary Outcome: Same as current

Information By: Peking University

Dates:
Date Received: May 8, 2013
Date Started: May 2013
Date Completion: June 2015
Last Updated: May 19, 2013
Last Verified: May 2013