NCT00388037

Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Study of Sunitinib (SU11248; NSC 736511) in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma. III. To document cancer antigen 125 (CA125) response rate, early objective progression rate, and, if objective responses are observed, response duration. OUTLINE: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Conditions

• Recurrent Fallopian Tube Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Primary Peritoneal Cavity Cancer
• Stage IIIA Fallopian Tube Cancer
• Stage IIIA Ovarian Epithelial Cancer
• Stage IIIA Primary Peritoneal Cavity Cancer
• Stage IIIB Fallopian Tube Cancer
• Stage IIIB Ovarian Epithelial Cancer
• Stage IIIB Primary Peritoneal Cavity Cancer
• Stage IIIC Fallopian Tube Cancer
• Stage IIIC Ovarian Epithelial Cancer
• Stage IIIC Primary Peritoneal Cavity Cancer
• Stage IV Fallopian Tube Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2006-10-13
• Last updated: 2015-01-27
• Results posted: 2015-01-15

Locations

1 site across 1 country: Canada