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


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.
Biagi
J J
JJ
Department of Oncology, Cancer Centre of South Eastern Ontario, Kingston, Ontario, Canada. jim.biagi@krcc.on.ca
Oza
A M
AM
Chalchal
H I
HI
Grimshaw
R
R
Ellard
S L
SL
Lee
U
U
Hirte
H
H
Sederias
J
J
Ivy
S P
SP
Eisenhauer
E A
EA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000097:blood; D018450:Disease Progression; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D012008:Recurrence; D000077210:Sunitinib; D016019:Survival Analysis
D000970:Antineoplastic Agents; D018394:CA-125 Antigen; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib