Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00377429
First received: September 15, 2006
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule 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 2

Study Type: Interventional
Study Design: 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:


Further study details as provided by Neovii Biotech:

Primary Outcome Measures:
  • Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.

  • Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Median Time of Progression-free Survival in Weeks (Post-study for 24 Months) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of Participants Who Survived (Post-study at 24 Month Visit) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die

  • Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: catumaxomab Drug: catumaxomab
Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
Other Name: Removab

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 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.

  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, 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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Stanford University of Obstetrics and Gynecology
Stanford, California, United States, 94305
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Illinois
Gynecologic Oncology - Hinsdale
Hinsdale, Illinois, United States, 60521
United States, Indiana
Michiana Hematology Oncology P.C.
South Bend, Indiana, United States, 46617
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Magee-Women Hospital of UPMC
Pittsburg, Pennsylvania, United States, 15213
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
Sponsors and Collaborators
Neovii Biotech
Fresenius Biotech North America
Investigators
Principal Investigator: Michael V Seiden, MD, Ph.D Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00377429     History of Changes
Other Study ID Numbers: IP-CAT-OC-01
Study First Received: September 15, 2006
Results First Received: March 15, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Neovii Biotech:
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 September 22, 2014