Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission
NCT01246440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2016-08-11
Summary
The purpose of this study is to evaluate the efficacy and safety of catumaxomab as consolidation treatment in patients with epithelial ovarian cancer in second or third complete remission.
Conditions
Interventions
- DRUG
-
Catumaxomab
Catumaxomab: 4 intraperitoneal infusions of catumaxomab over 11 days administered in a period of 3 hours through an intraperitoneal catheter with the following dosage: 1) 10 µg on Day 0. 2) 20 µg on Day 3. 3) 50 µg on Day 7. 4) 200 µg on Day 10.
Sponsors & Collaborators
-
Neovii Biotech
collaborator INDUSTRY -
Grupo Español de Investigación en Cáncer de Ovario
lead OTHER
Principal Investigators
-
Ana Oaknin, Dra. · Hospital de la Vall d'Hebron
-
Antonio Gonzalez, Dr. · M.D. Anderson
-
Miguel Beltran, Dr. · Institut Calatà d'Oncologia de Girona
-
Yolanda García, Dra. · Corporació Sanitaria Parc Tauli
-
Andrés Póveda, Dr. · Instituto Valenciano de Oncología
-
Ana Santaballa, Dra. · Hospital Universitario La Fe de Valencia
-
Mª Elena García, Dra. · Hospital José Maria Morales Meseguer
-
Andrés Redondo, Dr. · Hospital Universitario La Paz
-
Ana Herrero, Dra. · Hospital Miguel Servet
-
Juan Fernando Cuevas, Dr. · Hospital Clínico Universitario de Santiago de Compostela
-
Arantxa Gonzalez, Dra. · Hospital Son Dureta
-
Eva Guerra, Dra. · Hospital Universitario Ramon y Cajal
-
Jesus García, Dr. · Hospital Universitario Fundación Alcorcon
-
Jose Angel Arranz, Dr. · Hospital Gregorio Marañon
-
Ana de Juan, Dra. · Hospital Universitario de Valdecilla
-
Antonio Casado, Dr. · Hospital San Carlos, Madrid
-
César Mendiola, Dr. · Hospital Universitario 12 de Octubre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2014-02-28
- Completion
- 2014-12-31
Countries
- Spain
Study Locations
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