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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Avastin (bevacizumab) can help control certain cancers found during a second-look surgery. It targets individuals with Stage III-IV high-grade ovarian, fallopian tube, or primary peritoneal cancer who have already undergone surgery and chemotherapy. Participants should have had a second surgery revealing some remaining cancer and must have completed initial treatments successfully.

As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant cancer research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that bevacizumab, also known as Avastin, is generally well-tolerated by patients with ovarian cancer. In studies, about 87% of patients responded positively, with their cancer either shrinking or temporarily stopping its growth.

However, like any treatment, bevacizumab can cause side effects. Some reported side effects include high blood pressure and an increased risk of bleeding, but these are usually manageable with medical care.

Overall, bevacizumab is considered safe enough for clinical trials and is already approved for treating other types of cancer. This approval reflects a good level of confidence in its safety based on previous research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Bevacizumab is unique because it targets the blood vessels that supply tumors, essentially starving the cancer cells by blocking a protein called VEGF (vascular endothelial growth factor). Unlike traditional chemotherapy, which directly attacks cancer cells, Bevacizumab works by cutting off the tumor's blood supply, potentially reducing side effects and improving outcomes. Researchers are excited about Bevacizumab for ovarian cancer because it offers a different approach and may enhance the effectiveness of existing therapies, providing hope for improved survival rates.

What evidence suggests that this treatment might be an effective treatment for ovarian cancer?

Research has shown that bevacizumab, which participants in this trial will receive, can help treat ovarian cancer. One study found that patients who took bevacizumab after their initial surgery experienced more than six extra months without cancer progression. Other studies have demonstrated that adding bevacizumab to treatment plans can slow cancer progression for about a year. Additionally, patients who received six or more cycles of bevacizumab treatment lived longer overall. These findings suggest that bevacizumab could be a helpful option for managing ovarian cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Amir A. Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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, 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]

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-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, 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]

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, 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 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-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]

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