Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer
Status:
Completed
Trial end date:
2014-09-27
Target enrollment:
Participant gender:
Summary
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.