Chemotherapy +/− Bevacizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on maintenance biological or hormonal therapy, you are eligible as long as your recurrence is documented more than 6 months from the completion of primary chemotherapy and at least 4 weeks have passed since your last infusion of biological therapy.
What safety data exists for chemotherapy with or without Bevacizumab in ovarian cancer treatment?
Chemotherapy with carboplatin and paclitaxel is generally well-tolerated, but can cause significant blood-related side effects like low platelet and white blood cell counts. Bevacizumab, when added, may lead to high blood pressure, blood clots, bleeding, and joint pain. These treatments are considered safe for fit patients, but they do have notable side effects.12345
What makes the chemotherapy with or without bevacizumab treatment for ovarian cancer unique?
This treatment combines standard chemotherapy drugs with bevacizumab, an antiangiogenic agent that helps prevent the growth of new blood vessels that tumors need to grow. While it improves the time patients live without the cancer getting worse, it does not significantly increase overall survival rates.13678
What data supports the effectiveness of the drug combination including Bevacizumab, Carboplatin, Gemcitabine, and Paclitaxel for ovarian cancer?
Research shows that Paclitaxel and Carboplatin are effective for advanced ovarian cancer, and Gemcitabine has shown activity in platinum-resistant cases. Bevacizumab, when combined with platinum-based drugs like Carboplatin, has been used successfully in recurrent ovarian cancer, suggesting potential benefits of this combination.19101112
Who Is on the Research Team?
Robert L Coleman
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for patients with recurrent ovarian, epithelial, primary peritoneal, or fallopian tube cancer who responded well to initial platinum-taxane therapy and had a treatment-free period of at least 6 months. They must have measurable disease and be in good physical condition (GOG performance status of 0-2). Exclusions include those with more than one prior chemo regimen, previous radiotherapy to the abdomen/pelvis, certain other cancers within the last 5 years, severe medical problems unrelated to cancer, significant bleeding risks or CNS disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Eligible patients undergo abdominal exploration with cytoreduction
Treatment
Patients receive chemotherapy with or without bevacizumab, repeating every 21 days for 6-8 courses
Maintenance
Patients in Arm II receive maintenance bevacizumab every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Carboplatin
- Gemcitabine Hydrochloride
- Paclitaxel
Carboplatin is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator