Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer

Completed · Phase 2

Conditions studied: Ovarian Neoplasm, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

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 facts

Study ID

NCT00436215

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2006-12-12

Expected to finish

2014-09-27

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months of enrollment.
• Moderate or massive hemoptysis or surgery within 28 days of enrollment.
• Ongoing treatment with any other investigational agents.
• Brain metastases
• Patients with central nervous system (CNS) metastases within the past 2 years are ineligible. Patients who have had CNS disease curatively treated and without recurrence for 2 years may be eligible. but any CNS disease that has not undergone curative therapy with radiation, gamma knife, and/or surgical therapy are ineligible.
• CNS imaging will not be mandated for all patients. However, if there is clinical suspicion of CNS involvement, a contrast computed tomography (CT) or magnetic resonance imaging (MRI) of the brain will be required.
• Patients with CNS metastases may not be on steroids for the purpose of CNS disease or edema control.
• Patients with CNS disease must be on an anti-seizure medication and that medication cannot be a CYPP4503A modulating agent.
• Thrombotic or embolic events within the past 6 months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism, unstable angina, or myocardial infarction. Fully treated deep vein thrombosis no longer requiring anticoagulation will be allowed.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with evidence of active infection will become eligible for reconsideration 7 days after completing antibiotic therapy.
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib, bevacizumab, and/or the combination.
• Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management.
• Therapeutic anticoagulation with coumadin, heparins, or heparinoids.
• Evidence of a bleeding diathesis.
• History of high grade varices or arteriovenous malformations.
• Patients previously treated with sorafenib will not be eligible for this trial.
• Fistula or bowel obstruction or perforation in the 28 days prior to enrollment.
• Patients must not be taking the cytochrome p450 (CYP450) enzyme-inducing drugs phenytoin, carbamazepine, phenobarbital, St. John's wort, or rifampin.
• For patients who have been previously treated with bevacizumab, any severe toxicity associated with bevacizumab while the patient was being treated with the agent will make the patient ineligible for the trial. This includes bevacizumab-induced hypertensive crisis, arterial thromboembolic events (including cardiac ischemia or cerebrovascular ischemia or other arterial thrombosis), nephrotic syndrome, gastrointestinal perforation, serious hemorrhage, and fistulas (unless the fistula completely resolved while the patient was still on bevacizumab or it has been surgically corrected).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.