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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
Chiayi City, Taiwan
Department of Obstetrics & Gynecology Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Wan Fang Hospital, Taipei Medical University,
Taipei, Taiwan
Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)
Significant AEs include: 1. Hypertension ≥ grade 3 2. Proteinuria ≥ grade 3 3. GI perforation, abscesses and fistulae (any grade) 4. Wound healing complications ≥ grade 3 5. Haemorrhage ≥ grade 3 (any grade CNS bleeding; ≥ grade 2 haemoptysis) 6. Arterial thromboembolic events (any grade) 7. Venous thromboembolic events ≥ grade 3 8. PRES (any grade) 9. CHF ≥ grade 3 10. Non-GI fistula or abscess ≥ grade 2
Time frame: Up to 30 days after the last treatment
Progression free survival (PFS)
Following disease progression, the patient will be contacted every 26 weeks (+/- 2 weeks) (until 30 days after the last patient receives the last dose of bevacizumab) in order to capture their survival status
Time frame: Every 3 months during treatment and every 6 months for three years post-treatment
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Division of Gynecologic Oncology, Department of Obstetrics & Gynecology Chang Gung Memorial Hospital, Linkou Medical Center
Taoyuan District, Taiwan