Actively Recruiting
A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial
Led by British Columbia Cancer Agency · Updated on 2024-08-07
244
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two standard doses of the anti-cancer drug bevacizumab combined with chemotherapy in patients with epithelial ovarian cancer that is resistant to platinum-based chemotherapy. This pragmatic, randomized trial aims to compare a lower dose (7.5 mg/kg) versus a higher dose (15 mg/kg) of bevacizumab to see if the lower dose is not worse than the higher dose in controlling cancer progression while potentially reducing side effects and treatment costs. Participants will be randomly assigned to receive either 7.5 mg/kg or 15 mg/kg doses of bevacizumab every three weeks, combined with chemotherapy. The treatment duration will be determined by the treating clinicians based on standard care. The study compares progression-free survival, side effects, quality of life, and drug cost savings between the two dosing groups. During the study, participants will undergo regular CT scans to monitor disease progression, and side effects will be tracked. Quality of life assessments will be conducted during treatment and four weeks after stopping treatment. Researchers will follow participants for up to four years to assess progression-free survival and overall survival, along with treatment response duration and adverse events. Safety and treatment outcomes will be carefully monitored throughout the trial.
CONDITIONS
Brief 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 without curative therapy
- Disease resistant to platinum chemotherapy with progression within six months after platinum treatment
- Presence of clinically or radiologically documented measurable disease
- Measurable disease defined by specific size criteria on imaging or physical exam
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- At least one prior chemotherapy regimen including platinum treatment
- No prior treatment with anti-angiogenesis inhibitors like bevacizumab
- Approval of BC Cancer Compassionate Access Program (CAP) before treatment
- At least 28 days since last external beam radiation or major surgery, with healed wounds
- Women of childbearing potential must use effective contraception during and for 5 months after treatment
- Ability to give informed consent and be accessible for treatment and follow-up at the participating center
You will not qualify if you...
- History of other active or current cancers requiring treatment
- Serious medical conditions such as uncontrolled hypertension, active infections, or neurological/psychiatric disorders limiting compliance
- Concurrent treatment with other anti-cancer therapies or investigational drugs
- Neutrophil count less than 1 x 10^9/L
- Pregnancy or breastfeeding
- Bleeding disorders
- History of unresolved bowel obstruction
- Uncontrolled arterial or venous thromboembolism (controlled cases may be eligible)
- Myocardial infarction or stroke within past 4 months
- Untreated or uncontrolled brain metastases
- Open, non-healing wounds or unhealed fistulas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration until disease progression or discontinuation
Participants receive one of two standard doses of bevacizumab combined with chemotherapy to treat ovarian cancer. Treatment duration depends on the treating clinician's decision and follows standard care protocols.
Visits every 2 to 3 weeks for bevacizumab infusion, number depending on treatment length
Duration - Up to 4 years after treatment completion
Participants are monitored for side effects, quality of life, and survival outcomes after treatment ends.
Periodic visits for up to 4 months after last dose and quality of life assessments 4 weeks after treatment
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
W
Wilfred Hui
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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