Study on Bevacizumab for Ovarian Cancer Found During Second-Look Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02884648

Provider View

This clinical trial is exploring whether the drug Avastin (bevacizumab) can help control ovarian, fallopian tube, or primary peritoneal cancer that is discovered during a second-look surgery.

Patient Parameters

Program Overview

The aim of this study is to find out if the drug bevacizumab, also known as Avastin, can help manage ovarian, fallopian tube, or primary peritoneal cancer that is detected during a second-look surgery. Bevacizumab is already approved for treating several types of cancer, including ovarian cancer, but its use in this specific situation is still being investigated.

Description

Study Drug Administration:

If you qualify for the study, you will receive bevacizumab through an IV (intravenous) line over about 30 minutes on the first day of each 21-day cycle.

Study Visits:

Your first visit will be scheduled about 5-7 weeks after your second-look surgery to allow for recovery. The study doctor will inform you when your visits will begin.

During each cycle:

  • You will have a physical exam.
  • Blood samples (about 3 tablespoons) will be taken for routine tests. If you can become pregnant, part of this sample may be used for a pregnancy test if needed.

During Cycle 3 and every 3 cycles after that (Cycles 6, 9, 12, etc.), you will have an MRI or CT scan.

Length of Treatment:

You may continue receiving bevacizumab as long as it is beneficial according to the study doctor. Treatment will stop if the cancer worsens, if side effects become too severe, or if you cannot follow the study instructions.

Your participation will end after the final treatment visit.

End-of-Treatment Visit:

Within about 7 days after your last dose of bevacizumab:

  • You will have a physical exam.
  • Blood samples (about 3 tablespoons) will be taken for routine tests. If you can become pregnant, part of this sample will be used for a pregnancy test.

This study is investigational, meaning it is testing a new use of bevacizumab. Up to 35 participants will be enrolled, all at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent.
  • Age 18 or older.
  • Diagnosed with Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed standard surgery and chemotherapy (at least six cycles of platinum and taxane therapy).
  • Underwent second-look surgery at MD Anderson after a complete response to initial treatment.
  • Cancer confirmed during second-look surgery.
  • Willing to provide tissue samples from surgeries for the study.
  • Performance status of 0, 1, or 2 on the ECOG scale.
  • Adequate organ function based on specific lab tests.
  • Recovered from second-look surgery to start bevacizumab within 7 weeks.
  • Negative pregnancy test before starting treatment (unless surgically sterile or postmenopausal).
  • Women of childbearing potential must use two birth control methods or be surgically sterile or abstain from heterosexual activity during the study and for 120 days after the last dose.

Exclusion Criteria

  • Uncontrolled high blood pressure.
  • Mucinous or low-grade ovarian cancer.
  • BRCA mutations or HRD positivity.
  • Planned maintenance or additional therapy.
  • Psychiatric or substance abuse issues affecting study participation.
  • History of arterial thrombosis (DVT patients eligible if on anticoagulation).
  • History of certain medical conditions that increase risks with bevacizumab.
  • History of bleeding issues.
  • Inability to understand or comply with study requirements.
  • Use of other cancer treatments or vaccines.
  • Prior use of bevacizumab in initial treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.