A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Trial ID # NCT01305213
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, Fosbretabulin
Eligible Participant

Recurrent or persistent ovarian, fallopian tube, and primary peritoneal cancer; ≤ 3 prior therapies

Patients Enrolled

107

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

Fos+Bev vs Bev:

ORR: 35.7 vs 28.2% (p=0.24)
PFS: 7.3 vs. 4.8 months, HR=0.69 (0.47-1.00, p=0.05)
OS: 24.6 vs. 22.0 months, HR=0.85 (0.54-1.34, NS)

Exploratory analysis Pt status:
Pt-S (n=80): PFS: 7.6 vs 6.1 months; HR: 0.67 (p=0.14)
Pt-R (n=27): PFS: 6.7 vs 3.4 months; HR 0.57 (p=0.01)

Clinically Significant Adverse Events

Fos+Bev vs Bev:
Serious AE: none
Grade 2-4 AE: hypertension (35 vs 20%)

Conclusion

Improved PFS with addition of fosbretabulin

Reference

Monk BJ et al. Randomized Phase II Evaluation of Bevacizumab Versus Bevacizumab Plus Fosbretabulin in Recurrent Ovarian, Tubal, or Peritoneal Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol (2016) 34(19):2279-86
https://www.ncbi.nlm.nih.gov/pubmed/27217446