NCT02022917

Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer

A Phase II Trial of Postoperative Platinum-based Chemotherapy Plus Adjuvant and Maintenance Bevacizumab After Neoadjuvant Chemotherapy Followed by Interval Surgery in Patients With Extensive Stage IIIC or IV Ovarian, Tubal, and Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the feasibility of postoperative platinum-based chemotherapy plus adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.

Detailed description

This study is designed to determine the feasibility of administering adjuvant carboplatin, paclitaxel, and bevacizumab without unacceptable significant AE in patients with epithelial ovarian cancer after neoadjuvant carboplatin/cisplatin, and paclitaxel and interval cytoreductive surgery, primary peritoneal cancer or fallopian tube cancer. This study will also investigate progression free and to assess the quality of life. A Simon minimax two-stage design is employed to determine permit early stopping when a moderately long sequence of initial adverse events occurs. Under this two-stage design, 13 subjects are enrolled at the first stage. If there are \> 3 subjects discontinue treatment due to significant AE in the stage-1, then stop the trial. Otherwise, the second stage is implemented by including the other 14 subjects. The treatment safety will be evaluated and ensured by the occurrence rate of significant AE (or non AE). In stage-1, postoperative adjuvant cycles 2-6 will be observed for defined significant AE. Patients' or physicians' decision of discontinuation not because of the above-defined significant AEs or due to cancer progression should not be counted as an end-point event.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 15 mg/ Kg (from post-op cycle 2) intravenous infusion for 30 minutes in a 21 days' cycle for at least three cycles (best to 6 cycles) followed by 3-weekly maintenance bevacizumab 15 mg/ Kg intravenous infusion for 17 cycles.

Timeline

• Start date: 2014-03-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2013-12-30
• Last updated: 2021-01-27

Locations

5 sites across 1 country: Taiwan