Status:
COMPLETED
Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission
Lead Sponsor:
Grupo Español de Investigación en Cáncer de Ovario
Collaborating Sponsors:
Neovii Biotech
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Detailed Description
Epithelial ovarian cancer is the most lethal malignant gynecological tumor and the fourth most common cause of death by cancer among women. The highest incidence rates are observed in Eastern and Nort...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01246440
Start Date
June 1 2010
End Date
December 1 2014
Last Update
August 11 2016
Active Locations (17)
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1
Hospital de la Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
2
Institut Català d'Oncologia de Girona
Girona, Barcelona, Spain, 17007
3
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
4
Hospital Universitario de Valdecilla
Santander, Cantabria, Spain, 39008