Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00436215
Phase
PHASE2
Status
Completed

Conditions

  • Fallopian Tube Cancer
  • Ovarian Neoplasm
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    bevacizumab 5 mg/kg intravenous (IV) every two weeks
  • BAY 43-9006 — DRUG
    BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)

Study Details

Background: * Sorafenib and bevacizumab are anti-cancer drugs that work by targeting the blood vessels that allow tumors to grow. Using the two drugs together may more effectively block the formation of blood vessels that feed tumors. * Sorafenib and bevacizumab both are approved by the Food and Drug Administration for use in other cancers but have not ovarian cancer. In a preliminary trial of this drug combination, however, tumors in 6 of 14 patients with ovarian cancer shrank. Objectives: * To determine the safety and activity of the combination of sorafenib and bevacizumab for treating patients with ovarian, fallopian and peritoneal cancer. * To determine how sorafenib and bevacizumab may affect the cancer by measuring amounts of different proteins in small biopsy samples of tumor taken before starting treatment and after 6 weeks. Eligibility: * Females 18 years of age and older with ovarian, fallopian, or peritoneal cancer whose disease has not responded to standard treatment or for which no standard treatment is available. * Patients must have not been previously treated with bevacizumab or must have had their disease worsen while taking bevacizumab-based therapy. Design: * Patients take 200 mg of sorafenib by mouth twice a day Monday through Friday each week and 5 mg/kg of bevacizumab through a vein every 2 weeks. * Tumor biopsies and imaging scans (magnetic resonance imaging (MRI) and positron emission tomography (PET) are done before treatment, 3 days after beginning treatment, and 6 weeks into therapy. * Computed tomography (CT) or other imaging tests are done every 8 weeks to evaluate response to treatment. * History, physical examinations, blood and urine tests are done periodically during treatment for health checks and research purposes. * About 74 patients are to be enrolled in the trial.

Key Dates

First listed
Feb 19, 2007
Start date
Dec 12, 2006
Status verified
Nov 2020
Primary completion
Jun 26, 2014
Completion
Sep 27, 2014

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BAY 43-9006 + Bevacizumab
    BAY 43-9006 (sorafenib) + Bevacizumab

Primary Outcome Measure

Clinical Response Rate. [ Time Frame: patients were followed for a median of 18 weeks (range 1-116 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

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National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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