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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
Must not have
Uncontrolled arterial or venous thromboembolism
History of bowel obstruction or unresolved bowel obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an uncontrolled blood clotting issue.
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I have had a bowel obstruction or still have one.
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I have a bleeding disorder.
Select...
I have open wounds or fistulas that haven't healed.
Select...
I have untreated brain metastases.
Select...
I am not currently receiving any other cancer treatments or experimental drugs.
Select...
I do not have any other cancers that need treatment right now.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
progression-free survival
Secondary study objectives
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%
vitreous syneresis
9%
posterior capsule opacification
4%
cranial nerve VI palsy
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
176 Previous Clinical Trials
94,984 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
~6 spots leftby Jan 2025
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