NCT00469469

Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

A Phase II Study of Bevacizumab in Patients With Nonresectable Cancer of the Adrenal Cortex.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab

Timeline

• Start date: 2007-05-01
• Completion: 2009-09-01
• First posted: 2007-05-04
• Last updated: 2015-04-22

Locations

1 site across 1 country: United States