Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Patients with extensive and bulky disease are often those whose initial surgery is delayed
after 3 or 4 cycles of neo-adjuvant chemotherapy.
In that case, there is, indeed, some concern to administer bevacizumab during the
chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21
days) of this monoclonal antibody and the interference of anti angiogenic agents with wound
healing.
Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant
setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary
experience in cancer did not show a trend for increased incidence of fistula or bowel
perforation. For more details please refer to the investigator drug brochure for Vargatef®
(Nintedanib).
This trial will compare progression-free survival and surgical complications of 188 patients
with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy
(carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef®
(Nintedanib).