1052 Participants Needed

Chemotherapy +/− Bevacizumab for Ovarian Cancer

Recruiting at 795 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

RL

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

My cancer is of a specific type affecting the lining of organs.
My cancer responded completely to my initial platinum-taxane therapy.
I haven't had cancer treatment for 6 months and my cancer hasn't worsened.
See 10 more

Exclusion Criteria

I will start treatment with bevacizumab in my second cycle after surgery to reduce my tumor.
Patients with specific known hypersensitivity are excluded
I am currently receiving immunotherapy or radiotherapy.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Eligible patients undergo abdominal exploration with cytoreduction

1 week
1 visit (in-person)

Treatment

Patients receive chemotherapy with or without bevacizumab, repeating every 21 days for 6-8 courses

18-24 weeks
Every 3 weeks (in-person)

Maintenance

Patients in Arm II receive maintenance bevacizumab every 3 weeks

Varies based on response
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years
Every 3 months for 2 years, every 6 months for 3 years, then yearly

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Carboplatin
  • Gemcitabine Hydrochloride
  • Paclitaxel
Trial Overview The study tests if combining chemotherapy drugs carboplatin, paclitaxel and gemcitabine hydrochloride with the immunotherapy drug bevacizumab is more effective post-surgery than chemotherapy alone for treating recurrent ovarian-related cancers. Patients are randomly assigned to receive either just chemo or chemo plus bevacizumab after surgery.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)Experimental Treatment5 Interventions
Group II: Arm III (gemcitabine hydrochloride, carboplatin)Experimental Treatment4 Interventions
Group III: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)Experimental Treatment6 Interventions
Group IV: Arm I (paclitaxel, docetaxel, carboplatin)Active Control5 Interventions

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

🇺🇸
Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+

Published Research Related to This Trial

Cytoreductive surgery followed by platinum-based chemotherapy, particularly with carboplatin, remains the standard treatment for advanced epithelial ovarian cancer, but most patients are not cured, highlighting the need for improved therapies.
Paclitaxel, a novel agent effective in platinum-resistant ovarian cancer, is being tested in combination with platinum compounds in clinical trials for previously untreated patients, aiming to enhance treatment efficacy.
Treatment of ovarian cancer: current status.Ozols, RF.[2015]
Gemcitabine has shown promising results as a single-agent treatment for platinum-resistant ovarian cancer, achieving remission rates of nearly 20% with a favorable safety profile.
Combining gemcitabine with carboplatin has been explored in phase I and II trials, showing potential for improved efficacy in treating ovarian cancer, and further combinations with other agents are being actively researched.
Gemcitabine in ovarian cancer.Orlando, M., Mandachain, M.[2022]
In a phase 3 trial involving 682 patients with recurrent ovarian cancer, the combination of carboplatin-pegylated liposomal doxorubicin and bevacizumab showed a median progression-free survival of 13.3 months, significantly longer than the 11.6 months observed with the standard carboplatin-gemcitabine-bevacizumab regimen (p=0.012).
The safety profile was comparable between the two treatment groups, with hypertension and neutropenia being the most common severe adverse events; however, treatment-related deaths were rare, occurring in less than 1% of patients in both groups.
Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial.Pfisterer, J., Shannon, CM., Baumann, K., et al.[2022]

Citations

Treatment of ovarian cancer: current status. [2015]
Gemcitabine in ovarian cancer. [2022]
Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. [2022]
A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer. [2022]
Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study. [2022]
Taxane/platinum/anthracycline combination therapy in advanced epithelial ovarian cancer. [2015]
Arthralgia in patients with ovarian cancer treated with bevacizumab and chemotherapy. [2021]
Paclitaxel (Taxol)/carboplatin combination chemotherapy in the treatment of advanced ovarian cancer. [2015]
A phase II study of gemcitabine plus carboplatin in platinum-sensitive, recurrent ovarian carcinoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase III trials of standard chemotherapy with or without bevacizumab for ovarian cancer: a meta-analysis. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of bevacizumab plus paclitaxel and carboplatin regimen on prognostic survival of ovarian cancer patients. [2023]
Heterogeneous effects of cytotoxic chemotherapies for platinum-resistant ovarian cancer. [2023]
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