Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer - Full Text View - ClinicalTrials.gov
This study is not yet open for participant recruitment.
Verified April 2012 by ARCAGY/ GINECO GROUP
First Received on April 19, 2012.
Last Updated on April 23, 2012
History of Changes
| Sponsor: | ARCAGY/ GINECO GROUP |
|---|---|
| Information provided by (Responsible Party): | ARCAGY/ GINECO GROUP |
| ClinicalTrials.gov Identifier: | NCT01583322 |
Purpose
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).
