Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy - Full Text View

Sponsor:	Fresenius Biotech GmbH
Collaborator:	Fresenius Biotech North America
Information provided by:	Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:	NCT00377429

Purpose

The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

Condition	Intervention	Phase
Ovarian Cancer	Drug: catumaxomab	Phase II

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:	An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Catumaxomab

U.S. FDA Resources

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures:

To assess the rate of patients who complete a 4-dose series of catumaxomab infusions (defined as 10-20-50-150 mcg) within 21 days. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess humoral and cellular immune responses to catumaxomab therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To evaluate residual disease prior to and 3 months after catumaxomab treatment via 2nd-look and 3rd-look laparoscopy or laparotomy (these procedures are optional). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To assess progression-free survival (post-study for 24 months). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess overall survival (post-study for 24 months). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	September 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Catumaxomab administered as four 3-hour, constant-rate, IP infusions of 10, 20, 50, 150 mcg.

Detailed Description:

A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 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.

Eligibility

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

Criteria

Inclusion Criteria:

Signed and dated informed consent form before any protocol-specific screening procedures
Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, 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 CT scan and a CA-125 level below 35 U/mL
Age ≥18 years
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:

Acute or chronic systemic infection
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/mm3
Absolute neutrophil count (ANC) < 1,500 cells/mm3
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377429

Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States
United States, California
Stanford University of Obstetrics and Gynecology
Stanford, California, United States
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States
United States, Illinois
Gynecologic Oncology - Hinsdale
Hinsdale, Illinois, United States
United States, Indiana
Michiana Hematology Oncology P.C.
South Bend, Indiana, United States
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Magee-Women Hospital of UPMC
Pittsburg, Pennsylvania, United States
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States

Sponsors and Collaborators

Fresenius Biotech GmbH

Fresenius Biotech North America

Investigators

Principal Investigator:

Michael V Seiden, MD, Ph.D

Massachusetts General Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34.

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.

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.

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.

Responsible Party:	Manger of Regulatory Affairs, Fresenius Biotch North America
ClinicalTrials.gov Identifier:	NCT00377429 History of Changes
Other Study ID Numbers:	IP-CAT-OC-01
Study First Received:	September 15, 2006
Last Updated:	June 24, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Fresenius Biotech GmbH:

Epithelial Cancer
Epithelial Carcinoma
Epithelial Ovarian Cancer
Epithelial Ovarian Carcinoma
Fallopian Tube Cancer
Fallopian Tube Carcinoma
Ovarian Cancer

Ovarian Carcinoma
Ovarian Epithelial Cancer
Ovarian Epithelial Carcinoma
Peritoneal Cancer
Peritoneal Carcinoma
Advanced Epithelial Ovarian Cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female

Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012