NCT02884648

Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery

A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Drug Administration: If you are found to be eligible to take part in the study, you will receive bevacizumab by vein over about 30 minutes on Day 1 of every 21-day study cycle. Study Visits: Your first study visit will be about 5-7 weeks after your second-look surgery so that you have time to recover. The study doctor will tell you when you will start having study visits. During all cycles: * You will have a physical exam. * Blood (about 3 tablespoons) will be drawn for routine testing. If you can become pregnant and the doctor thinks it is needed, part of this routine blood sample may be used for a pregnancy test. During Cycle 3 and then every 3 cycles after that (Cycles 6, 9, 12, and so on), you will have an MRI or CT scan. Length of Treatment: You may continue to receive bevacizumab for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the end-of-treatment visit. End-of-Treatment Visit: Within about 7 days after your last dose of bevacizumab: * You will have a physical exam. * Blood (about 3 tablespoons) will be drawn for routine testing. If you can become pregnant, part of this sample will be used for a pregnancy test. This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of several types of cancer, including ovarian cancer. However, it is considered investigational to use bevacizumab as treatment for cancer found during second-look surgery. The study doctor will explain how the study drug is designed to work. Up to 35 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Malignant Neoplasms of Female Genital Organs
• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg by vein on Day 1 of every 21-day study cycle.

Timeline

• Start date: 2016-11-15
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2016-08-31
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study