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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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

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 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.

Inclusion Criteria:

- Signed and dated informed consent form before any protocol-specific screening

- 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:

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Michael V Seiden, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

February 2008

Related Keywords:

  • Ovarian Cancer
  • 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
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Arizona Cancer Center Tucson, Arizona  85724
James Graham Brown Cancer Center Louisville, Kentucky  40202
Florida Hospital Cancer Institute Orlando, Florida  32804
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Massachusetts General Hospital Boston, Massachusetts  02114-2617
South Carolina Oncology Associates Columbia, South Carolina  29201
University of New Mexico Albuquerque, New Mexico  87131
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Stanford University of Obstetrics and Gynecology Stanford, California  94305
Gynecologic Oncology - Hinsdale Hinsdale, Illinois  60521
Michiana Hematology Oncology P.C. South Bend, Indiana  46617
Magee-Women Hospital of UPMC Pittsburg, Pennsylvania  15213