NCT00093626

Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

A Phase II Evaluation of BAY 43-9006 (Sorafenib, Nexavar®, NCI-Supplied Agent, NSC #724772) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma. II. Determine 6-month progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug, in terms of frequency and severity of adverse events encountered, in these patients. SECONDARY OBJECTIVES: I. Determine the clinical response rate (partial and complete response) in patients treated with this drug. II. Determine the duration of progression-free and overall survival of patients treated with this drug. III. Correlate prognostic variables (platinum sensitivity, performance status, and histology \[clear cell and mucinous type\]) with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 6-13 months.

Conditions

• Primary Peritoneal Carcinoma
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sorafenib Tosylate	Given orally

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-09-01
• Completion: 2011-01-01
• First posted: 2004-10-08
• Last updated: 2019-07-23

Locations

1 site across 1 country: United States