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Monoclonal Antibodies

Bevacizumab for Ovarian Cancer

Phase 2
Recruiting
Led By Amir A. Jazaeri, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have adequate organ function as determined by the following laboratory values: a) absolute neutrophil count (ANC) >/= 1,000 /mcL; b) Platelets >/= 100,000/mcL; (c) Hgb >/= 8 g/dL; (d) Creatinine Clearance >/= 40 mL/min (measured or calculated per local practice); (e) Total Bilirubin </= 1.5 × upper limit of normal (ULN) or </= 3 × ULN in the case of suspected/documented Gilbert's Syndrome; and (f) AST (SGOT) and ALT (SGPT) </= 2.5 X ULN
Have undergone a second-look surgery by an MD Anderson Gynecologic Oncology faculty after having achieved a complete clinical response to frontline surgery and adjuvant chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or positron emission computed tomography (PET)-CT of abdomen and pelvis or other equivalent imaging, and (c) normalization of CA125 (<35 U/mL)
Must not have
Documented germline or somatic BRCA mutations and/or HRD positivity
Histology showing mucinous or low-grade epithelial ovarian carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights

Summary

This trial is testing if Avastin can help to control ovarian, fallopian, or primary peritoneal cancer after it has been found during second-look surgery.

Who is the study for?
This trial is for women aged 18 or older with Stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers. They must have completed standard frontline treatment and surgery, be recovered from second-look surgery, not pregnant, and willing to use birth control. Exclusions include a history of certain bleeding disorders, uncontrolled hypertension, prior bevacizumab use in the frontline setting, and specific genetic mutations.Check my eligibility
What is being tested?
The study tests if Bevacizumab (Avastin) can control ovarian cancer found during second-look surgery after patients achieved a complete clinical response to initial treatment. It examines the effectiveness of Bevacizumab on those who've had standard chemotherapy and are showing signs of residual cancer at this stage.See study design
What are the potential side effects?
Bevacizumab may cause side effects such as high blood pressure; bleeding issues including nosebleeds; wounds that don't heal properly; gastrointestinal perforations; kidney problems leading to protein loss in urine; infusion reactions like fever or chills; fatigue; low white blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts and kidney, liver functions are within required ranges.
Select...
I've had a follow-up surgery after successful initial cancer treatment and my tests show no signs of cancer.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has BRCA mutations or is HRD positive.
Select...
My ovarian cancer is either mucinous or low-grade.
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I have previously been treated with bevacizumab or its equivalent.
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I am not using, nor do I plan to use, any other cancer treatments besides the trial.
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I have had bleeding in my lungs, stomach, or brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

1Treatment groups
Experimental Treatment
Group I: BevacizumabExperimental Treatment1 Intervention
Participants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,244 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,710 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,366 Total Patients Enrolled
288 Trials studying Ovarian Cancer
73,670 Patients Enrolled for Ovarian Cancer
Amir A. Jazaeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Ovarian Cancer
9 Patients Enrolled for Ovarian Cancer

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02884648 — Phase 2
Ovarian Cancer Research Study Groups: Bevacizumab
Ovarian Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02884648 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02884648 — Phase 2
~2 spots leftby Feb 2025
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