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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: Catumaxomab	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	June 2010
Actual Primary Completion Date :	February 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Progression-free survival (PFS) [ Time Frame: 3 years ]
   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 :

1. Second progression-free survival (2PFS) [ Time Frame: 3 years ]
   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.
2. Third progression-free survival (3PFS) [ Time Frame: 3 years ]
   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.
3. Progression-free survival per protocol [ Time Frame: 3 years ]
   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.
4. First progression-free survival [ Time Frame: 3 years ]
   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.
5. Duration of the treatment-free interval [ Time Frame: 3 years ]
   Measured from the date of the administration of the last dose of catumaxomab until the date of the beginning of the following salvage treatment.
6. Overall survival rate [ Time Frame: 3 years ]
   Measured from the date of the first administration of the study treatment (catumaxomab Day 0) until the death of the patient.
7. Incidence, intensity and causalidad of every adverse event. [ Time Frame: 3 years ]
   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.
8. Therapeutic compliance [ Time Frame: 3 years ]
   Compliance and percentage of patients being given the 4th dose of catumaxomab in accordance with the treatment plan, Day 10.
9. The level of cells involved in the immune response [ Time Frame: 3 years ]
   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)
10. Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab [ Time Frame: 3 years ]
    Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Locations

Spain
Institut Català d'Oncologia de Girona
Girona, Barcelona, Spain, 17007
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Universitario 12 de Octubre
Madrid, Madrdi, Spain, 28041
Hospital Universitario Fundación Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital de la Vall d'Hebron
Barcelona, Spain, 08035
Hospital Gregorio Marañon
Madrid, Spain, 28007
M.D. Anderson
Madrid, Spain, 28033
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Son Dureta
Mallorca, Spain, 07014
Hospital Jose Maria Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario de Valdecilla
Santander, Spain, 39008
Hosptial Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46009
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Miguel Servet
Zaragoza, Spain, 50009

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Secretaría Técnica GEICO, Antonio Gonzalez (Chairman GEICO), Grupo Español de Investigación en Cáncer de Ovario
ClinicalTrials.gov Identifier:	NCT01246440 History of Changes
Other Study ID Numbers:	GEICO-1001; 2010-018478-19 ( EudraCT Number )
First Posted:	November 23, 2010
Last Update Posted:	August 11, 2016
Last Verified:	August 2016

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