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Monoclonal Antibodies

Bevacizumab Dosing for Ovarian Cancer

Phase 2
Recruiting
Led By Jenny Ko
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Platinum resistant disease (progression within six months of completing a platinum-containing protocol). In this case, progression from the last line of therapy would be defined as radiologic progression by RECIST 1.1 criteria on CT or MR
Patients must be >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 years
Awards & highlights

Study Summary

This trial is testing whether a lower dose of an anti-cancer drug is just as effective as a higher dose, in ovarian cancer patients whose disease is resistant to platinum chemotherapy.

Who is the study for?
This trial is for adults with advanced, metastatic, or recurrent epithelial ovarian cancer that's resistant to platinum chemotherapy. Participants must have tried at least one chemo regimen including platinum and can't have used anti-angiogenesis inhibitors like bevacizumab before. They should be in good enough health to follow the trial procedures and agree to use effective contraception.Check my eligibility
What is being tested?
The study compares two standard doses of bevacizumab (7.5 mg/kg vs. 15 mg/kg) combined with chemotherapy in patients with ovarian cancer who don't respond well to platinum-based treatments. It aims to see if a lower dose is just as effective without causing more side effects.See study design
What are the potential side effects?
Bevacizumab may cause high blood pressure, bleeding issues, slow wound healing, kidney problems, fatigue, and increased risk of infections among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer got worse within 6 months after platinum-based treatment.
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I am 18 years old or older.
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My cancer can be measured by standard health guidelines.
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I have never been treated with drugs that stop the formation of blood vessels in cancer.
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I am able to get out of my bed or chair and move around.
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My cancer (ovarian, peritoneal, or fallopian tube) cannot be surgically removed and has no cure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 4 years 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
Secondary outcome measures
Compare treatment-emergent grade 3-5 AEs
Duration of response
Estimate drug cost savings
+2 more

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

2Treatment groups
Experimental Treatment
Active Control
Group I: Lower standard dosing bevacizumab plus chemotherapyExperimental Treatment1 Intervention
bevacizumab 7.5mg/kg + chemotherapy
Group II: Higher Standard dosing as per standard regimenActive Control1 Intervention
bevacizumab 15mg/kg + chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,267 Total Patients Enrolled
5 Trials studying Ovarian Cancer
127 Patients Enrolled for Ovarian Cancer
Jenny KoPrincipal InvestigatorBC Cancer

Media Library

Ovarian Cancer Research Study Groups: Higher Standard dosing as per standard regimen, Lower standard dosing bevacizumab plus chemotherapy
Ovarian Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04787289 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04787289 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned Bevacizumab for medical use?

"Our team has assigned bevacizumab a score of 2 on the safety scale, as there is evidence of its protective effects but no confirmations regarding efficacy."

Answered by AI

How many participants are involved in this research project?

"This trial is no longer recruiting participants, with the last update occurring on July 19th 2021. If you are searching for other pastures, 682 clinical trials involving patients suffering from platinum-resistant ovarian cancer (PROC) and 355 studies utilizing Bevacizumab are current enrolling individuals."

Answered by AI

Could you please detail the other investigations involving Bevacizumab?

"Currently, 355 clinical trials are actively studying Bevacizumab. 89 of these studies have reached the third and final phase; most of which can be found in Taibei, Taiwan with 17017 other locations running their own individual trials for this medication."

Answered by AI

Is there a current call for participants in this exploration?

"Unfortunately, according to the data published on clinicaltrials.gov this particular study is no longer recruiting patients. This trial was initially posted September 1st 2021 and underwent its final update July 19th of that same year. There are currently 1037 other trials actively searching for subjects however."

Answered by AI

What maladies does Bevacizumab usually address?

"Bevacizumab is often prescribed to combat malignant neoplasms and has been known to help patients with recurrent platinum sensitive primary peritoneal cancer, advanced stage iv epithelial ovarian cancer after initial surgery, and locally progressed nonsquamous non-small cell lung cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Jenny Ko 2021. "A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04787289.
~55 spots leftby Jan 2025
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