Chemotherapy + Bevacizumab for Ovarian & Related Cancers

Recruiting at 632 trial locations

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 phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Research Team

John K Chan

Principal Investigator

NRG Oncology

Eligibility Criteria

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

Your white blood cell count is at least 1,500 per microliter.

Your SGOT level must be less than or equal to 3 times the upper limit of normal.

My nerve damage symptoms are mild or not present.

Exclusion Criteria

You are allergic to Chinese hamster ovary cell products or other genetically engineered antibodies.

I am expecting to undergo or have undergone an invasive procedure.

I am experiencing symptoms of a blockage in my digestive tract.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Carboplatin (Alkylating agents)
• Paclitaxel (Anti-metabolites)

Trial Overview The study tests how well paclitaxel works when given once every three weeks versus weekly in combination with carboplatin and possibly bevacizumab. Bevacizumab is an antibody that blocks blood vessel growth needed by tumors. The effectiveness of these treatments on various types of ovarian-related cancers is being compared.

Participant Groups

Group I: Arm II (neoadjuvant chemotherapy) Experimental Treatment 5 Interventions

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Group II: Arm I (adjuvant chemotherapy suboptimally debulked) Experimental Treatment 5 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

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+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+