Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy
NCT ID: NCT00377429
Last Updated: 2012-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2006-09-30
2008-02-29
Brief Summary
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Detailed Description
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Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells \[DCs\] and natural killer \[NK\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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catumaxomab
catumaxomab
Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
Interventions
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catumaxomab
Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stage IIb - IV
* Optimal or sub-optimal cytoreductive surgery
* Clinical complete response to platinum and taxane-based therapy consisting of at least four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125) level below 35 U/mL
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the start of catumaxomab treatment
* Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility)
* Willingness of patients of childbearing potential to use an effective contraceptive method (i.e. oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion
Exclusion Criteria
* Exposure to chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer therapy within 6 weeks of first dose of catumaxomab other than last regimen of platinum and taxane chemotherapy as outlined in protocol
* Known human immunodeficiency virus (HIV) infection
* Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies (mAb)
* Inadequate renal function (creatinine \> 1.5 x upper limit of normal \[ULN\])
* Inadequate hepatic function:
* Alanine aminotransferase (ALT) \> 2.5 x ULN or
* Aspartate aminotransferase (AST) \> 2.5 x ULN or
* Bilirubin \> 1.5 x ULN
* Platelets \< 100,000 cells/mm\^3
* Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3
* History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within the last 6 months
* No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix if adequately treated
* No history of brain metastases
* Any further condition or disease that would, in the opinion of the Investigator, expose the patient to undue risk
18 Years
FEMALE
No
Sponsors
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Fresenius Biotech North America
INDUSTRY
Neovii Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Michael V Seiden, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Stanford University of Obstetrics and Gynecology
Stanford, California, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Gynecologic Oncology - Hinsdale
Hinsdale, Illinois, United States
Michiana Hematology Oncology P.C.
South Bend, Indiana, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico
Albuquerque, New Mexico, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Magee-Women Hospital of UPMC
Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Countries
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References
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Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
Other Identifiers
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IP-CAT-OC-01
Identifier Type: -
Identifier Source: org_study_id