A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study — Ann Oncol

A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study
J. J. Biagi1,*, A. M. Oza2, H. I. ChalChal3, R. Grimshaw4, S. L. Ellard5, U. Lee6, H. Hirte7, J. Sederias8, S. P. Ivy9 and E. A. Eisenhauer8


Ann Oncol (2011) 22 (2): 335-340.
doi: 10.1093/annonc/mdq357
First published online: August 12, 2010


+ Author Affiliations
1Department of Oncology, Cancer Centre of South Eastern Ontario, Kingston, Ontario
2Department of Medicine, Princess Margaret Hospital, University Health Network, Toronto, Ontario
3Department of Medicine, Allan Blair Cancer Centre, Regina, Saskatchewan
4Department of Obstetrics and Gynecology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia
5Department of Medicine, BC Cancer Agency—Southern Interior Centre, Kelowna, British Columbia
6Department of Medicine and BC Cancer Agency—Fraser Valley Centre, Surrey, British Columbia
7Department of Medicine, Juravinski Cancer Centre, Hamilton, Ontario
8Department of Oncology and NCIC-Clinical Trials Group, Queen’s University, Kingston, Ontario, Canada
9National Cancer Institute, Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program, Investigational Drug Branch, Bethesda, MD, USA


*Correspondence to: Dr J. J. Biagi, Department of Oncology, Cancer Centre of South Eastern Ontario, 25 King Street W, Kingston, Ontario, Canada K7L 5P9. Tel: +1-613-544-2630; Fax: +1-613-546-8209; E-mail: jim.biagi@krcc.on.ca

Received February 19, 2010.
Revision received May 24, 2010.
Accepted May 25, 2010.


Abstract
Purpose: Sunitinib is a multitargeted receptor tyrosine kinase inhibitor. We conducted a two-stage phase II study to evaluate the objective response rate of oral sunitinib in recurrent epithelial ovarian cancer.

Patients and methods: Eligibility required measurable disease and one or two prior chemotherapies, at least one platinum based. Platinum-sensitive or -resistant disease was allowed. Initial dose schedule was sunitinib 50 mg daily, 4 of 6 weeks. Observation of fluid accumulations during off-treatment periods resulted in adoption of continuous 37.5 mg daily dosing in the second stage of accrual.

Results: Of 30 eligible patients, most had serous histology (67%), were platinum sensitive (73%) and had two prior chemotherapies (60%). One partial response (3.3%) and three CA125 responses (10%) were observed, all in platinum-sensitive patients using intermittent dosing. Sixteen (53%) had stable disease. Five had >30% decrease in measurable disease. Overall median progression-free survival was 4.1 months. Common adverse events included fatigue, gastrointestinal symptoms, hand–foot syndrome and hypertension. No gastrointestinal perforation occurred.

Conclusions: Single-agent sunitinib has modest activity in recurrent platinum-sensitive ovarian cancer, but only at the 50 mg intermittent dose schedule, suggesting that dose and schedule may be vital considerations in further evaluation of sunitinib in this cancer setting.

A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study — Ann Oncol