search
Back to results

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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
catumaxomab
Sponsored by
Neovii Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center
  • Stanford University of Obstetrics and Gynecology
  • Florida Hospital Cancer Institute
  • Gynecologic Oncology - Hinsdale
  • Michiana Hematology Oncology P.C.
  • James Graham Brown Cancer Center
  • Massachusetts General Hospital
  • Dartmouth-Hitchcock Medical Center
  • University of New Mexico
  • Wake Forest University Health Sciences
  • Magee-Women Hospital of UPMC
  • South Carolina Oncology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

catumaxomab

Arm Description

Outcomes

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

Secondary Outcome Measures

Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy
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)
Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)
Number of Participants Who Survived (Post-study at 24 Month Visit)
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)

Full Information

First Posted
September 15, 2006
Last Updated
July 16, 2012
Sponsor
Neovii Biotech
Collaborators
Fresenius Biotech North America
search

1. Study Identification

Unique Protocol Identification Number
NCT00377429
Brief Title
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovii Biotech
Collaborators
Fresenius Biotech North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
catumaxomab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
catumaxomab
Other Intervention Name(s)
Removab
Intervention Description
Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy
Description
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.
Time Frame
2 months
Title
Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)
Time Frame
Baseline
Title
Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)
Time Frame
2 years
Title
Number of Participants Who Survived (Post-study at 24 Month Visit)
Description
Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die
Time Frame
2 years
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael V Seiden, MD, Ph.D
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Stanford University of Obstetrics and Gynecology
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Gynecologic Oncology - Hinsdale
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Michiana Hematology Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Magee-Women Hospital of UPMC
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15906359
Citation
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.
Results Reference
background
PubMed Identifier
11588051
Citation
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.
Results Reference
background
PubMed Identifier
11410615
Citation
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.
Results Reference
background
PubMed Identifier
10901380
Citation
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.
Results Reference
background
PubMed Identifier
10415020
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs