phase 2: Vargatef (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer - Full Text View - ClinicalTrials.gov - France) (treatment/placebo/note: Avastin...)

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).