A Phase 2 study of cediranib in recurrent or persistent ovarian, peritoneal or fallopian tube cancer

Abstract

 A Trial of the Princess Margaret, Chicago and California Phase II Consortia
 Highlights

• •Cediranib has activity in recurrent ovarian cancer
• •Expected toxicities were manageable with a dose reduction of cediranib (30 mg daily)

 Purpose

Cediranib is a potent multitargeted inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2 and 3. The study was initiated to evaluate the activity of cediranib in patients (pts) with recurrent ovarian, peritoneal or fallopian tube cancer (OC).

Methods

Eligible pts had persistent/recurrent OC following one prior platinum-based chemotherapy with measurable disease or progression based on Gynecologic Cancer Inter Group CA-125 criteria. Because of toxicities observed in the first 23 pts, the initial starting dose of oral daily (od) cediranib was reduced from 45 mg to 30 mg. The primary endpoint was objective response rate at 16 weeks. This study was stratified into two arms: platinum-sensitive (PL-S) and platinum-resistant (PL-R).

Results

74 pts were enrolled; 39 were PL-S and 35 PL-R, with a median age of 58 years [31–87]. In PL-S group, 10 partial responses (PR) and stable disease (SD) in 20 (51%) were confirmed while in the PL-R arm there were no confirmed PR and 23 pts (66%) had SD. The main grade 3/4 toxicities were hypertension (24%), fatigue (17%) and diarrhea (9%). The median progression-free survival for all patients was 4.9 months [3.9-7.0], 7.2 months [4.3-9] for PL-S and 3.7 months [2.6-4.5] for PL-R group. The median overall survival was 18.9 months (95% CI: 13.5-31.5); 27.7 months [17.8-43.3] for PL-S and 11.9 months [8.1-18.9] for PL-R group.

Conclusion

Cediranib shows significant activity in recurrent platinum sensitive OC. The toxicities were expected and manageable at the dose of 30 mg od.