A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865) (GOG 0213)

Trial ID # NCT00565851; GOG-213
Phase III
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, Carboplatin, Paclitaxel
Eligible Participant

Platinum-sensitive ovarian cancer at first recurrence

Patients Enrolled

674

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac+Bev vs CarboPt+Pac:

ORR: 78 vs 59% (p<0.0001, n=509)
PFS: 13.8 vs 10.4 months, HR: 0.61 (0.52-0.72, p<0.0001)
OS: 42.2 vs 37.3 months, HR: 0.82 (0.68-0.996, p=0.045, audited treatment-free interval stratification analysis)

Clinically Significant Adverse Events

CarboPt+Pac+Bev vs CarboPt+Pac:
Serious AE: treatment-related deaths: 3% (9 patients) vs 1% (2 patients)
Grade 3-4 AE: any (96 vs 86%), infections (13 vs 6%), pain (16 vs 5%), hypertension (14 vs 2%), GI (12 vs 6%)

Conclusion

Improved ORR, PFS and OS with the addition of bevacizumab

Reference

Coleman RL et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol (2017) 18(6):779-791
https://www.ncbi.nlm.nih.gov/pubmed/28438473