Chemotherapy +/− Bevacizumab for Ovarian Cancer

Recruiting at 795 trial locations

Overseen by Robert L Coleman

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Research Team

Robert L Coleman

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Carboplatin (Alkylating agents)
• Gemcitabine Hydrochloride (Anti-metabolites)
• Paclitaxel (Anti-microtubule agent)

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.

Participant Groups

Group I: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) Experimental Treatment 5 Interventions

Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.

Group II: Arm III (gemcitabine hydrochloride, carboplatin) Experimental Treatment 4 Interventions

Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.

Group III: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) Experimental Treatment 6 Interventions

Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.

Group IV: Arm I (paclitaxel, docetaxel, carboplatin) Active Control 5 Interventions

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School