Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: Sutent sunitinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

Detailed description:
This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients). There was 42% probability of stopping the trial at stage one if the true OR rate was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0.05.

Arms:
arm 1: Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.

Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: None

Protocol document: