NCT04787289

A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer

A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study team proposes to compare 2 standard doses of an anti-cancer drug called bevacizumab, 7.5mg/kg per dose vs. 15mg/kg per dose, given in combination with chemotherapy in patients with ovarian cancer that progressed on platinum chemotherapy. Higher doses in cases of antibody-based drugs like bevacizumab are not always better than lower doses, and in fact can cause more side effects without improving survival or shrinkage of cancer. Both 7.5 and 15mg/kg doses of bevacizumab every 3 weeks are used as standard protocol in BC Cancer for ovarian cancer patients, but only 15mg/kg doses are allowed for patients with ovarian cancer that progressed on platinum chemotherapy. This study is a pragmatic two-arm blinded study in which 70 patients with platinum-resistant ovarian cancer and eligible for bevacizumab + chemotherapy will be randomly assigned either to lower or higher standard dose of bevacizumab , combined with chemotherapy. Treating clinicians will decide how long the treatment will continue per standard of care. Duration of cancer control on CT scans, side effect profiles, and quality of life related to the two arms will be compared. If demonstrated, this finding will be practice-changing, with comparable efficacy and quality of life, potentially improved safety profile, as well as reduced provincial drug costs.

Conditions

• Ovarian Cancer
• Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Low standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)

Timeline

• Start date: 2021-09-10
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2021-03-08
• Last updated: 2024-08-07

Locations

2 sites across 1 country: Canada