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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 adequately recovered from second look surgery to be able to start bevacizumab within 7 weeks of this procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights

Study 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.
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I have recovered from my recent surgery and can start treatment within 7 weeks.
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I've completed at least 6 cycles of specific chemotherapy for my cancer.
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I've had a follow-up surgery after successful initial cancer treatment and my tests show no signs of cancer.
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My ovarian cancer was confirmed during a follow-up surgery.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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I am 18 years old or older.
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I have signed the consent form in my preferred language.
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I can take care of myself and am up and about more than half of my waking hours.
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I am using two birth control methods or am not having sex to join this study.
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I agree to let my previously collected tissue samples be used for this study.

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
2,962 Previous Clinical Trials
1,803,330 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,710 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,312 Total Patients Enrolled
285 Trials studying Ovarian Cancer
73,673 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted to this clinical trial?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is actively enrolling, with the first posting having been on November 1st 2016 and the most recent edit being made on January 3rd 2022. The study has need for 35 patients at a single medical centre."

Answered by AI

Has Bevacizumab been granted authorization from the FDA?

"Evidence concerning the safety of Bevacizumab is limited to Phase 2 trials, so it received a score of two. No data exists that confirms its efficacy yet."

Answered by AI

For what diseases and ailments is Bevacizumab commonly prescribed?

"Bevacizumab can be employed to combat malignant neoplasms, recurrent platinum-sensitive primary peritoneal cancer, and Stage IV epithelial ovarian cancer post-surgical excision."

Answered by AI

Could you please provide a compendium of research regarding Bevacizumab?

"Presently, there are 355 clinical trials involving Bevacizumab with 89 of those studies being in Phase 3. Of the 17017 sites researching this medication, many reside in Taibei, Taiwan."

Answered by AI

Are researchers currently recruiting participants for this investigation?

"The clinicaltrials.gov webpage indicates that this medical trial is currently accepting applicants, having opened on the 1st of November 2016 and been updated most recently on 3rd January 2022."

Answered by AI
~4 spots leftby Feb 2025