drugset / Trial / NCT01802749

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer

NCT01802749 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

Timeline

Start
2013-11
Primary completion
2023-12
Completion
2023-12

Outcome

Met primary endpoint

paper Median progression-free survival was 8·8 months (95% CI 8·4-9·3) in the standard chemotherapy group and 11·8 months (10·8-12·9) in the bevacizumab group PMID 33539744 ↗

paper hazard ratio 0·51, 95% CI 0·41-0·65; log-rank p<0·0001 PMID 33539744 ↗

paper Continuing bevacizumab beyond progression combined with chemotherapy in patients with platinum-sensitive recurrent ovarian cancer improves progression-free survival compared with standard chemotherapy alone PMID 33539744 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule 4 unknown Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Pegylated liposomal doxorubicin Unknown 30 mg/m2 Intravenous

Indications