Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer (CHIVA)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum|
- Median Progression-free Survival (PFS) in each study arm [ Time Frame: average of 18 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 2 months after beginning of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
400 mg (200 mg twice daily) Route of administration= oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).
Continuous daily dosing until progression of disease or until criteria for interruption of treatment are met, no intake of Vargatef® (Nintedanib) on days of paclitaxel and carboplatin administration. The maximum time on monotherapy is 2 years.
|Placebo Comparator: placebo||
Contains 0 mg of Vargatef® (Nintedanib) in capsules matching 100 mg and 150 mg of Vargatef® (Nintedanib) Route of administration: oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).
Continuous daily dosing until progression of disease or until criteria for interruption of treatment is met, no intake of placebo on days of paclitaxel and carboplatin administration.
The maximum time on monotherapy is 2 years.
|Contact: Frédéric Marmion, Msc||01 42 34 83 firstname.lastname@example.org|
|Centre Paul Papin||Recruiting|
|Institut Ste Catherine||Recruiting|
|Polyclinique Bordeaux Nord||Recruiting|
|centre Francois baclesse||Recruiting|
|Centre Georges François leclerc||Recruiting|
|Centre Oscar Lambret||Recruiting|
|Lyon, France, 69000|
|Contact: Thomas BACHELOT, Md + 33 4 78 78 26 54 email@example.com|
|Centre Léon bérard||Recruiting|
|Centre Alexis Vautrin||Recruiting|
|Centre Catherine de Sienne||Recruiting|
|Centre Hospitalier Régional||Recruiting|
|Contact: Jérôme ALEXANDRE, PhD|
|Principal Investigator: Jérôme ALEXANDRE, PhD|
|Centre Hospitalier Lyon-sud||Recruiting|
|Pierre-Bénite, France, 69495|
|Contact: Gilles Freyer, MD, PhD + 33 (0) 478863324|
|Principal Investigator: Gilles Freyer, MD, PhD|
|Institut Jean Godinot||Recruiting|
|Centre Henri Becquerel||Recruiting|
|Clinique Armoricaine de Radiologie||Recruiting|
|Saint Brieuc, France|
|ICO René Gauducheau||Recruiting|
|St Herblain, France|
|Centre Claudius Régaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Laurence GLADIEFF, physician 05 61 42 41 19|
|Principal Investigator: Laurence GLADIEFF, physician|
|Principal Investigator:||Gwénaël Ferron, MD||Institut Claudius Régaud|