Sunitinib in Treating Patients With Advanced or Metastatic Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with advanced or metastatic recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Drug: sunitinib malate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma|
- Objective response as assessed by RECIST criteria [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Drug: sunitinib malate
37.5 mg PO Daily for 4 weeks
- Determine the efficacy, in terms of response rate, of sunitinib malate in patients with advanced or metastatic recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.
- Determine the toxicity of this regimen in these patients.
- Document CA125 response rate, early objective progression rate, and response duration.
OUTLINE: This is a nonrandomized, open label, multicenter study.
Patients receive oral sunitinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||James Biagi, MD||Cancer Centre of Southeastern Ontario at Kingston General Hospital|