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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01246440 on ClinicalTrials.gov