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

NCT01246440 | Completed Phase 2

• 2 other identifiers: GEICO-10012010-018478-19
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 17

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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.

  3 years

Secondary Outcomes (10)

• Second progression-free survival (2PFS)

  3 years

• Third progression-free survival (3PFS)

  3 years

• Progression-free survival per protocol

  3 years

• First progression-free survival

  3 years

• Duration of the treatment-free interval

  3 years

Study Arms (1)

Catumaxomab

EXPERIMENTAL

Drug: Catumaxomab

Interventions

Catumaxomab DRUG

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.

Catumaxomab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Español de Investigación en Cáncer de Ovario: lead
• Neovii Biotech: collaborator

Study Sites (17)

Hospital de la Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Institut Català d'Oncologia de Girona

Girona, Barcelona, 17007, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrdi, 28041, Spain

Location

Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

M.D. Anderson

Madrid, Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Son Dureta

Mallorca, Mallorca, 07014, Spain

Location

Hospital Jose Maria Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hosptial Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Santiago de Compostela, 15706, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, Valencia, 46009, Spain

Location

Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ana Oaknin, Dra.

  Hospital de la Vall d'Hebron

  STUDY CHAIR

• Antonio Gonzalez, Dr.

  M.D. Anderson

  STUDY CHAIR

• 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 San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• César Mendiola, Dr.

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Antonio Gonzalez (Chairman GEICO)

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 23, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

ES (17)