Clinical Trial: Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex.
Brief Summary: This is a Phase II study of intravenous Bevacizumab in patients with pathologically confirmed nonresectable primary adrenocortical cancer (ACC). Patients must have received no prior therapy. They will receive Bevacizumab as a single agent every 2 weeks intravenously until disease progression. This study will be open at multiple sites.
Detailed Summary: Adrenocortical carcinoma(ACC)is a rare malignancy with an incidence of 1.5 to 2 per million per year in the United states. Surgery is the only therapeutic option that can prolong survival. Currently there are no therapies that have been proven to prolong survival for patients with nonsurgically resectable disease. ACC has been shown to be highly resistant to standard chemotherapy, therefore, it is important that we test agents with mechanisms of action. This is a single arm phase II study of Bevacizumab, an angiogenesis inhibitor, given as a single agent at 10 mg/kg IV every 2 weeks in patients with unresectable ACC. Bevicizumab will be used as first line therapy. The study will test if Bevacizumab will be able to prolong the time to progression. If a delay in time to progression of 4 months or greater is seen, this will be considered clinically meaningful and further studies will be considered. This study will be conducted at multiple institutions (see below).
Sponsor: Dartmouth-Hitchcock Medical Center
Current Primary Outcome: To measure time to progression [ Time Frame: From date of first dose of Bevacizumab until progression. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To Measure objective response rate by RECIST [ Time Frame: At the end of treatment, RECIST criteria will be used to determine the patient's best overall response. ]
- To determine an adverse event profile [ Time Frame: Measured from date of first treatment until 30 days post treatment. ]
- To measure survival in all treated patients. [ Time Frame: Survival is measured from the date of first treatment to date of death form any cause. ]
Original Secondary Outcome: Same as current
Information By: Dartmouth-Hitchcock Medical Center
Dates:
Date Received: May 2, 2007
Date Started: May 2007
Date Completion: September 2009
Last Updated: April 21, 2015
Last Verified: May 2008
