Actively Recruiting
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Led by British Columbia Cancer Agency · Updated on 2024-08-07
244
Participants Needed
2
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A pragmatic, two armed, study comparing 2 standard doses of an anti-cancer drug called bevacizumab, given in combination with Chemotherapy. The study will be offered to ovarian cancer patients whose disease is platinum chemotherapy resistant . Higher doses of anti-cancer based drugs are not always better than lower doses and can cause more side effects without improvement of cancer. These patients will be randomly assigned either 7.5 mg/kg or 15mg/kg of bevacizumab combined with chemotherapy . Comparing these two doses will determine if the lower dose-level is non-inferior, and could lead to practice changes.
CONDITIONS
Official Title
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma that is advanced, metastatic, recurrent, or unresectable with no curative therapy
- Disease progression within six months after platinum-containing chemotherapy
- Presence of clinically and/or radiologically documented disease
- Measurable disease by RECIST 1.1 criteria (specific size requirements for chest x-ray, CT scan, physical exam, or lymph nodes)
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- At least one prior chemotherapy regimen including platinum; other therapies allowed
- No prior treatment with anti-angiogenesis inhibitors including bevacizumab
- Approval of BC Cancer Compassionate Access Program (CAP) request before treatment
- At least 28 days elapsed since last external beam radiation
- At least 28 days elapsed since major surgery with healed wounds
- Women of childbearing potential agree to use highly effective contraception during study and for 5 months after last treatment
- Ability to provide informed consent
- Available for treatment and follow-up at participating center
You will not qualify if you...
- History of other active or current malignancies requiring treatment
- Serious medical conditions that may worsen with treatment or limit compliance, including significant neurologic or psychiatric disorders, uncontrolled hypertension, active serious infections, or other aggravating medical conditions
- Receiving concurrent anti-cancer therapy or investigational agents
- Neutrophil count less than 1 x 10^9/L
- Pregnancy or breastfeeding
- Bleeding disorders
- History of bowel obstruction or unresolved bowel obstruction
- Uncontrolled arterial or venous blood clots (controlled cases may be eligible)
- Myocardial infarction or stroke within the past 4 months
- Untreated or uncontrolled central nervous system metastases
- Open, non-healing wounds or known fistulas that have not healed
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Abbotsford Centre, BC Cancer Agency
Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
Actively Recruiting
2
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z4E6
Actively Recruiting
Research Team
J
Jenny Ko
CONTACT
W
Wilfred Hui
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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