Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00436215|
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : March 26, 2015
Last Update Posted : August 29, 2017
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasm Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Bevacizumab Drug: BAY 43-9006||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sorafenib and Bevacizumab in Epithelial Ovarian, Fallopian, and Peritoneal Cancer|
|Actual Study Start Date :||December 12, 2006|
|Actual Primary Completion Date :||June 26, 2014|
|Actual Study Completion Date :||September 27, 2014|
Experimental: BAY 43-9006 + Bevacizumab
BAY 43-9006 (sorafenib) + Bevacizumab
bevacizumab 5 mg/kg intravenous (IV) every two weeks
Other Name: Avastin
Drug: BAY 43-9006
BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)
Other Name: sorafenib
- Clinical Response Rate. [ Time Frame: patients were followed for a median of 18 weeks (range 1-116 weeks) ]Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.
- Progression-free Survival [ Time Frame: up to 28 months ]Progression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.
- Number of Participants With Adverse Events [ Time Frame: up to 28 months ]Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436215
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christina M Annunziata, M.D.||National Cancer Institute (NCI)|