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