Chemotherapy + Bevacizumab for Ovarian & Related Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two chemotherapy drugs, paclitaxel and carboplatin, with or without bevacizumab (also known as Avastin), in treating advanced ovarian, primary peritoneal, or fallopian tube cancers. Paclitaxel and carboplatin aim to stop cancer cell growth, while bevacizumab helps prevent tumors from obtaining the blood supply they need. The trial compares two schedules for administering paclitaxel to determine which is more effective. Ideal participants are those diagnosed with stage II-IV ovarian, primary peritoneal, or fallopian tube cancer with measurable disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
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 certain blood thinners like warfarin, you may need to maintain a specific dose. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of paclitaxel and carboplatin is generally well-tolerated by patients with ovarian cancer. This drug combination is a common and standard treatment for this type of cancer. One study found no significant difference in safety whether administered weekly or every three weeks. Another study confirmed the effectiveness of using paclitaxel and carboplatin together without causing unexpected side effects.
Patients in earlier trials demonstrated that this chemotherapy combination is manageable. However, like any cancer treatment, some side effects such as nausea or tiredness can occur, but healthcare providers usually expect and monitor these.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of chemotherapy with Bevacizumab for ovarian and related cancers because it adds a unique approach to tackling these conditions. Bevacizumab is an antibody that targets and inhibits a protein called VEGF, which is responsible for the growth of blood vessels that feed tumors. This mechanism of action is different from traditional chemotherapy, which directly kills cancer cells. By combining Bevacizumab with standard chemotherapy drugs like Carboplatin and Paclitaxel, there's potential for a more effective treatment that not only attacks cancer cells but also cuts off their nutrient supply, potentially improving outcomes for patients.
What evidence suggests that this trial's treatments could be effective for ovarian and related cancers?
Research has shown that using paclitaxel and carboplatin together is a common and effective treatment for ovarian cancer. This combination helps stop cancer cells from growing and spreading. In this trial, participants in Arm I will receive paclitaxel and carboplatin every three weeks, while those in Arm II will receive paclitaxel weekly and carboplatin every three weeks. One study found that changing the schedule of paclitaxel from every three weeks to weekly did not significantly affect how long patients lived without the cancer worsening. Bevacizumab, another drug used in some studies, helps stop the tumor from growing by cutting off its blood supply, making it a strong addition in certain cases. Overall, the paclitaxel and carboplatin combination is a reliable choice for treating these cancers.13456
Who Is on the Research Team?
John K Chan
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Eligible participants must have a certain level of physical fitness (GOG performance status 0-2), adequate organ function, measurable disease, and no prior chemotherapy for abdominal/pelvic tumors. They cannot join if they have certain other health conditions like active bleeding risks or allergies to specific drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive paclitaxel and carboplatin with or without bevacizumab. Treatment repeats every 21 days for 6 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Carboplatin
- Paclitaxel
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator