A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable

PHASE2CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

February 1, 2013

Primary Completion Date

August 17, 2016

Study Completion Date

August 17, 2016

Conditions
Ovarian Cancer
Interventions
DRUG

Carboplatin

Carboplatin will be administered at a dose calculated according to the Calvert formula (\[participant's glomerular filtration rate + 25\] multiplied by the target area under the concentration-time curve \[AUC\] of 5 milligrams per milliliter per minute \[mg/mL/min\]), as intravenous \[IV\] infusion over 30-60 minutes \[min\] every 3 weeks).

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 175 milligrams per meter-squared \[mg/m\^2\] as IV infusion over 3 hours using a rate controlling device every 3 weeks, or at a dose of 80 mg/m\^2 as IV infusion over 1 hour using a rate controlling device every week (only during Cycles 5 to 8).

DRUG

Bevacizumab

Bevacizumab will be administered at a dose of 15 milligrams per kilogram \[mg/kg\] as IV infusion over 30-90 min every 3 weeks.

Trial Locations (15)

13273

Institut J Paoli I Calmettes; Chir II, Marseille

14076

Centre Francois Baclesse; Chir Gynecologique, Caen

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

31059

Hopital Rangueil; CHIR Generale Et Gynecologique, Toulouse

33076

Institut Bergonie; Oncologie, Bordeaux

34298

Centre Val Aurelle Paul Lamarque; Chir A1, Montpellier

59020

Centre Oscar Lambret; Cancerologie Gynecologique, Lille

63011

Centre Jean Perrin; Chir Generale Oncologie, Clermont-Ferrand

75231

Institut Curie; Chir Generale Gyneco Oncologique, Paris

75908

Hop Europeen Georges Pompidou; Gynecologie, Paris

75970

HOPITAL TENON; Cancerologie Medicale, Paris

80054

Chu D'Amiens, Amiens

92210

Centre Rene Huguenin; Chir Generale Oncologique, Saint-Cloud

94805

Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn, Villejuif

06189

Centre Antoine Lacassagne; Hopital De Jour A2, Nice

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01739218 - A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable | Biotech Hunter | Biotech Hunter