Bevacizumab for Ovarian Cancer

Overseen By Amir A. Jazaeri, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticancer therapies

Disqualifiers: Uncontrolled hypertension, BRCA mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: As long as the study doctor thinks it is in participant's best interest

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any other anti-cancer systemic chemotherapy, biological therapy, radiation therapy, or live cancer vaccines while participating in the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use any other anti-cancer treatments while participating in this study.

What data supports the idea that Bevacizumab for Ovarian Cancer (also known as: Bevacizumab, Avastin) is an effective drug?

The available research shows that Bevacizumab, when added to standard chemotherapy, helps patients with ovarian cancer by delaying the time it takes for the cancer to get worse. In studies like GOG-0218 and ICON7, patients who received Bevacizumab with chemotherapy lived longer without their cancer progressing compared to those who only received chemotherapy. This suggests that Bevacizumab is effective in managing ovarian cancer. Additionally, Bevacizumab has been shown to be beneficial for patients with recurrent ovarian cancer, as seen in the OCEANS study. While there are some side effects, the drug generally has an acceptable safety profile. ^{1 2 3 4 5}

What evidence supports the effectiveness of the drug Bevacizumab for ovarian cancer?

Research shows that adding Bevacizumab to standard chemotherapy significantly prolongs the time patients live without their cancer getting worse, especially in advanced ovarian cancer. This drug works by blocking a protein that helps tumors grow new blood vessels, which is crucial for their growth. ^{1 2 3 4 5}

What safety data is available for Bevacizumab in treating ovarian cancer?

Bevacizumab, also known as Avastin, has been evaluated in multiple clinical trials for ovarian cancer. Phase II and III trials have shown that while it improves progression-free survival, it does not significantly impact overall survival. Common adverse events associated with Bevacizumab include hypertension, bleeding, thromboembolism, proteinuria, delayed wound healing, and gastrointestinal issues. Most of these side effects are mild and manageable, but some, like arterial thromboembolism and gastrointestinal perforation, can be serious. The safety profile of Bevacizumab is consistent across studies, and it has been approved in Europe and the United States for treating ovarian cancer. ^{6 7 8 9 10}

Is Bevacizumab safe for humans?

Bevacizumab, also known as Avastin, has been studied for safety in humans and is generally considered safe, though it can cause side effects like high blood pressure, bleeding, and protein in the urine. Some rare but serious side effects include blood clots, wound healing problems, and gastrointestinal issues. Most side effects can be managed by doctors. ^{6 7 8 9 10}

Is the drug Bevacizumab (Avastin) a promising treatment for ovarian cancer?

Yes, Bevacizumab (Avastin) is a promising drug for treating ovarian cancer. It has been shown to help slow down the progression of the disease when used with chemotherapy, and it is approved for use in both newly diagnosed and recurrent cases of ovarian cancer. ^{1 2 3 11 12}

How is the drug Bevacizumab unique in treating ovarian cancer?

Bevacizumab is unique because it targets and blocks a protein called VEGF, which is involved in the growth of blood vessels that supply tumors, helping to slow down the progression of ovarian cancer. It is used in combination with chemotherapy and has been shown to prolong the time patients live without the disease getting worse, although it does not increase overall survival. ^{1 2 3 11 12}

Research Team

Amir A. Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women aged 18 or older with Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers. They must have completed standard frontline treatment and surgery, be recovered from second-look surgery, not pregnant, and willing to use birth control. Exclusions include a history of certain bleeding disorders, uncontrolled hypertension, prior bevacizumab use in the frontline setting, and specific genetic mutations.

Inclusion Criteria

My blood counts and kidney, liver functions are within required ranges.

I have recovered from my recent surgery and can start treatment within 7 weeks.

I've completed at least 6 cycles of specific chemotherapy for my cancer.

Exclusion Criteria

History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the Study

My cancer has BRCA mutations or is HRD positive.

I am planning to undergo ongoing cancer treatment after initial therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5-7 weeks

1 visit (in-person)

Treatment

Participants receive bevacizumab by vein on Day 1 of every 21-day study cycle

As long as the study doctor thinks it is in participant's best interest

1 visit every 21 days (in-person)

Monitoring

During Cycle 3 and then every 3 cycles after that, participants will have an MRI or CT scan

Every 9 weeks

1 visit every 9 weeks (in-person)

End-of-Treatment

Within about 7 days after the last dose of bevacizumab, participants will have a physical exam and blood tests

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bevacizumab

Trial Overview The study tests if Bevacizumab (Avastin) can control ovarian cancer found during second-look surgery after patients achieved a complete clinical response to initial treatment. It examines the effectiveness of Bevacizumab on those who've had standard chemotherapy and are showing signs of residual cancer at this stage.

Participant Groups

Group I: Bevacizumab Experimental Treatment 1 Intervention

Participants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Bevacizumab, an anti-VEGF monoclonal antibody, has shown significant efficacy in treating epithelial ovarian cancer (EOC) when added to chemotherapy, as demonstrated in four positive randomized trials involving both front-line and recurrent cases.

The ongoing debate in clinical practice is not whether to use bevacizumab, but rather when to use it, as considerations of efficacy, toxicity, quality of life, and cost-effectiveness play crucial roles in determining the optimal treatment setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating bevacizumab into the management of epithelial ovarian cancer: the controversy of front-line versus recurrent disease. Monk, BJ., Pujade-Lauraine, E., Burger, RA.[2020]

Bevacizumab, when combined with carboplatin and paclitaxel, significantly prolongs progression-free survival in women with newly diagnosed advanced ovarian cancer, as shown in the GOG-0218 and ICON7 studies.

In patients with recurrent platinum-sensitive ovarian cancer, bevacizumab combined with carboplatin and gemcitabine also extends progression-free survival, demonstrating its efficacy in both first-line and second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Dhillon, S.[2019]

Bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be effective in treating recurrent high-grade serous ovarian cancer, leading to its regulatory approval in many countries, including the US in 2014.

While bevacizumab is widely used and integrated into ovarian cancer treatment guidelines, it does not increase cure rates, highlighting the need for predictive biomarkers to better tailor treatments and weigh the benefits against costs and potential toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-angiogenic agents in ovarian cancer: past, present, and future. Monk, BJ., Minion, LE., Coleman, RL.[2023]

In two major phase III clinical trials (GOG-0218 and ICON7) involving women with advanced ovarian cancer, bevacizumab combined with standard chemotherapy significantly improved progression-free survival compared to chemotherapy alone.

While there was a temporary decline in health-related quality of life during chemotherapy with bevacizumab, overall tolerability was acceptable, and adverse events were similar to those seen in other solid tumor treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Dhillon, S.[2021]

Bevacizumab, a monoclonal antibody that targets VEGF, has shown anticancer activity in ovarian cancer, both as a single agent and in combination with chemotherapy, leading to its FDA approval for several cancers.

While bevacizumab can be effective, there is a significant risk of gastrointestinal perforation, especially in patients who have been heavily pretreated, which is an important consideration for patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and its use in epithelial ovarian cancer. Matulonis, UA.[2019]

Bevacizumab, an anti-VEGF therapy, has shown efficacy in treating epithelial ovarian cancers, both as a standalone treatment and in combination with other therapies, based on evidence from Phase II trials involving various patient populations.

While most side effects of bevacizumab, such as proteinuria and hypertension, are mild and manageable, there are serious but rare risks like arterial thromboembolism and gastrointestinal perforation, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. Burger, RA.[2015]

Bevacizumab, a targeted therapy for ovarian cancer, has shown significant improvement in progression-free survival when combined with standard chemotherapy, although it does not extend overall survival.

While bevacizumab can lead to adverse effects like hypertension and bleeding, these can generally be managed effectively, and the treatment has been approved in Europe and the U.S. for its benefits, including improved quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical appraisal of bevacizumab in the treatment of ovarian cancer. Yoshida, H., Yabuno, A., Fujiwara, K.[2018]

Bevacizumab (BV) has been shown to significantly improve progression-free survival in patients with advanced ovarian cancer when combined with standard chemotherapy, although it does not extend overall survival.

While BV is associated with some adverse events like hypertension and bleeding, these can generally be managed effectively, and it also enhances the quality of life for patients with recurrent ovarian cancer, particularly regarding abdominal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in ovarian cancer: A critical review of phase III studies. Rossi, L., Verrico, M., Zaccarelli, E., et al.[2022]

In a study of 46 patients with advanced and recurrent epithelial ovarian cancer treated with bevacizumab and chemotherapy over 30 months, the most common adverse events were hypertension (65.2%) and proteinuria (49%), with hypertension typically occurring 2 months after treatment initiation.

Patients with a history of radiation therapy experienced a significantly higher risk of gastrointestinal perforation, indicating that careful consideration is needed when administering bevacizumab to these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. Yokoyama, Y., Kubo-Kaneda, M., Sunada, K., et al.[2022]

Bevacizumab, an anti-angiogenic agent, has been approved for use in advanced ovarian cancer and has shown significant efficacy when combined with standard chemotherapy in multiple phase III trials involving women with ovarian cancer.

While bevacizumab's safety profile aligns with expectations, ongoing research is necessary to identify markers that can predict patient response to optimize treatment outcomes, and new anti-angiogenic agents are currently being evaluated in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in combination with chemotherapy for the treatment of advanced ovarian cancer: a systematic review. Aravantinos, G., Pectasides, D.[2023]

Bevacizumab, an anti-VEGF antibody, shows promise as a treatment for epithelial ovarian cancer, either alone or in combination with standard chemotherapy drugs like carboplatin and paclitaxel, based on several Phase II studies and ongoing Phase III trials.

While bevacizumab has been generally well tolerated by patients, there is a noted increased risk of gastrointestinal perforations, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in the treatment of ovarian cancer. Han, ES., Monk, BJ.[2015]

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor-A, has shown response rates of 16-21% as a single-agent treatment for recurrent ovarian cancer, indicating its efficacy in this context.

In combination with standard chemotherapy for advanced ovarian cancer, bevacizumab significantly improves progression-free survival, although it does not enhance overall survival; the main safety concern is hypertension, with rare but serious risks including gastrointestinal perforation and toxicity to the kidneys and central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and ovarian cancer. Garcia, A., Singh, H.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Integrating bevacizumab into the management of epithelial ovarian cancer: the controversy of front-line versus recurrent disease. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Anti-angiogenic agents in ovarian cancer: past, present, and future. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Bevacizumab and its use in epithelial ovarian cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of bevacizumab in the treatment of ovarian cancer. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Bevacizumab in ovarian cancer: A critical review of phase III studies. [2022]

9. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Bevacizumab in combination with chemotherapy for the treatment of advanced ovarian cancer: a systematic review. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Bevacizumab in the treatment of ovarian cancer. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Bevacizumab and ovarian cancer. [2021]