Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Grupo Español de Investigación en Cáncer de Ovario.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Neovii Biotech
Information provided by:
Grupo Español de Investigación en Cáncer de Ovario
ClinicalTrials.gov Identifier:
NCT01246440
First received: November 18, 2010
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Catumaxomab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II of Intraperitoneal Catumaxomab as a Consolidation Therapy in Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma in Second or Third Complete Clinical Disease Remission

Resource links provided by NLM:


Further study details as provided by Grupo Español de Investigación en Cáncer de Ovario:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Progression-free survival per protocol is defined as the period from the commencement of the consolidation treatment (catumaxomab Day 0) and the recurrence of the disease or the last follow-up for the patients not developing a recurrence.


Secondary Outcome Measures:
  • Second progression-free survival (2PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    In patients in second complete remission, measured from the beginning of the treatment for the first recurrence until the date of the second recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.

  • Third progression-free survival (3PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    In patients in third complete remission, measured from the beginning of the treatment for the second recurrence until the date of the third recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.

  • Progression-free survival per protocol [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured from the date of the beginning of the study treatment (catumaxomab Day 0) until the recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.

  • First progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Which has to be recorded retrospectively, measured from the date of the initial treatment for the ovarian cancer (neoadjuvant chemotherapy or cytoreductive surgery) until the date of the first recurrence of the disease.

  • Duration of the treatment-free interval [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured from the date of the administration of the last dose of catumaxomab until the date of the beginning of the following salvage treatment.

  • Overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured from the date of the first administration of the study treatment (catumaxomab Day 0) until the death of the patient.

  • Incidence, intensity and causalidad of every adverse event. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The incidence, intensity and possible causality of every adverse event (AE). AEs will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 4.0.

  • Therapeutic compliance [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Compliance and percentage of patients being given the 4th dose of catumaxomab in accordance with the treatment plan, Day 10.

  • The level of cells involved in the immune response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The level of cells involved in the immune response, including sub-populations of the T lymphocytes, B lymphocytes, "natural killer" cells, and antigen-processing cells measured in a sample of ovarian cancer (optional study)

  • Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab


Estimated Enrollment: 39
Study Start Date: June 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catumaxomab 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed consent.
  • Initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma
  • Women ≥ 18 years
  • ECOG performance status ≤ 1 (Eastern Cooperative Oncology Groupperformance)
  • Initial surgical cytoreduction as primary treatment combinated with Platinum- based chemotherapy administered as part of primary therapy.

Failure of the primary treatment as manifested by recurrent disease that have achieved a second or third complete response with a second or third-line chemotherapy (platinum-based or not).

The complete response to the second or third-line chemotherapy is defined as non symptoms of cancer persistence, normal CA-125 (cancer antigen 125), negative medical examination, and no evidence of disease in a TAC.

  • At least 4 cycles of second or third-line chemotherapy must have been administered
  • Surgery performed at first or second relapse in conjunction with second or third-line chemotherapy is permitted.

Exclusion Criteria:

  • Acute or chronic infection
  • Concomitant treatment with cancer chemo- and/or radiotherapy
  • Exposure to an investigational product within 28 days of first infusion
  • Previous treatment with murine monoclonal antibodies
  • Inadequate renal function: creatinine >1.5 upper limit of normal [ULN] and/ or calculated creatinine clearance ≥ 50 mL/min
  • Inadequate hepatic function (AST, ALT, >2.5 xULN; bilirubin >1.5 xULN), Hypoalbuminaemia < 3 g/dL
  • Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1000 cells/mm3,
  • Hb < 8g/dL and PTT > 2 x ULN
  • Patients with occlusive intestinal or symptomatic sub-occlusive intestinal within the last 30 days.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
  • Unable or unwilling to comply fully with the protocol.
  • Any co-morbid disease that would increase risk of toxicity according to investigator judgment
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
  • Exposure to investigational product, cancer, chemo-or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion
  • Known or suspected hypersensitivity to catumaxomab or similar antibodies
  • Long-lasting steroid treatment (≥ 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246440

Contacts
Contact: Ana Oaknin, Dra. +34 932746085 amoaknin@vhebron.net
Contact: Antonio Gonzalez, Dr. +34917878605 agonzalezm@seom.org

Locations
Spain
Institut Català d'Oncologia de Girona Not yet recruiting
Girona, Barcelona, Spain, 17007
Corporació Sanitaria Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Yolanda García, Dra.    +34 652 185 972    ygarcia@tauli.cat   
Contact: Jose Manuel García, DM    +34 937242759    jgarciaR@tauli.cat   
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Madrdi, Spain, 28041
Hospital Universitario Fundación Alcorcon Not yet recruiting
Alcorcon, Madrid, Spain, 28922
Hospital de la Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Ana Oaknin, Dra.    +34 932746085    amoaknin@vhebron.net   
Hospital Universitario Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
M.D. Anderson Recruiting
Madrid, Spain, 28033
Contact: Antonio González, Dr.    +34 917878605    agonzalezm@seom.org   
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Gregorio Marañon Not yet recruiting
Madrid, Spain, 28007
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Son Dureta Recruiting
Mallorca, Spain, 07014
Contact: Arantxa González, Dra.    +34 97 117 52 30    aranzazu.gonzalezdelalba@ssib.es   
Hospital Jose Maria Morales Meseguer Not yet recruiting
Murcia, Spain, 30008
Hospital Universitario de Valdecilla Not yet recruiting
Santander, Spain, 39008
Hosptial Clinico Universitario de Santiago de Compostela Not yet recruiting
Santiago de Compostela, Spain, 15706
Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
Contact: Andrés Póveda, Dr.    +34 96 111 40 00    apoveda@fivo.org   
Hospital Universitario La Fe de Valencia Recruiting
Valencia, Spain, 46009
Contact: Ana Santaballa, Dra.    +34 96 197 31 88    santaballa_ana@gva.es   
Hospital Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Ana Herrero, Dra.    +34 97 676 55 00 ext 3825    herreroa@yahoo.es   
Sponsors and Collaborators
Grupo Español de Investigación en Cáncer de Ovario
Neovii Biotech
Investigators
Study Chair: Ana Oaknin, Dra. Hospital de la Vall d'Hebron
Study Chair: Antonio Gonzalez, Dr. M.D. Anderson
Principal Investigator: Miguel Beltran, Dr. Institut Calatà d'Oncologia de Girona
Principal Investigator: Yolanda García, Dra. Corporació Sanitaria Parc Tauli
Principal Investigator: Andrés Póveda, Dr. Instituto Valenciano de Oncología
Principal Investigator: Ana Santaballa, Dra. Hospital Universitario La Fe de Valencia
Principal Investigator: Mª Elena García, Dra. Hospital José Maria Morales Meseguer
Principal Investigator: Andrés Redondo, Dr. Hospital Universitario La Paz
Principal Investigator: Ana Herrero, Dra. Hospital Miguel Servet
Principal Investigator: Juan Fernando Cuevas, Dr. Hospital Clínico Universitario de Santiago de Compostela
Principal Investigator: Arantxa Gonzalez, Dra. Hospital Son Dureta
Principal Investigator: Eva Guerra, Dra. Hospital Universitario Ramon y Cajal
Principal Investigator: Jesus García, Dr. Hospital Universitario Fundación Alcorcon
Principal Investigator: Jose Angel Arranz, Dr. Hospital Gregorio Marañon
Principal Investigator: Ana de Juan, Dra. Hospital Universitario de Valdecilla
Principal Investigator: Antonio Casado, Dr. Hospital Clínico San Carlos
Principal Investigator: César Mendiola, Dr. Hospital Universitario 12 de Octubre
  More Information

No publications provided

Responsible Party: Dra. Ana Oaknin, Grupo Español de Investigación en Cáncer de Ovario
ClinicalTrials.gov Identifier: NCT01246440     History of Changes
Other Study ID Numbers: GEICO-1001, 2010-018478-19
Study First Received: November 18, 2010
Last Updated: November 24, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014