A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed

Trial ID #	NCT00097019
Phase	II
Drug Class	Angiogenesis Inhibitors: VEGF
Drug Name	Bevacizumab
Alternate Drug Names	immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial	Bevacizumab
Eligible Participant	Primary platinum resistant disease or platinum resistant disease that failed subsequent treatment with Doxil or Topotecan, ≤ 3 prior therapies
Patients Enrolled	44; median 2 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 15.9% (7PR) PFS: 4.4 months OS: 10.7 months
Clinically Significant Adverse Events	Serious AE: three deaths related to bevacizumab treatment Grade 3-4 AE: proteinuria (15.9%), hypertension (9.1%), arterial thrombolic events (6.8%) GI perforation 11.4% (23.8% in patients with three prior therapies, 0% in patients with two or fewer therapies)
Conclusion	Single-agent activity in platinum-resistant patients but risk of GI-related adverse events
Reference	Cannistra SA et al. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol (2007) 25(33):5180-6 https://www.ncbi.nlm.nih.gov/pubmed/18024865