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A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EMD 72000
Sponsored by
EMD Serono
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring EGFR; HER-1; monoclonal antibody; targeted therapy

Eligibility Criteria

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

Inclusion Criteria: Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease Immunohistochemical evidence of tumor EGFR (HER-1) expression At least one measurable lesion according to the WHO criteria Life expectancy ≥ 12 weeks ECOG performance status 0-1 Exclusion Criteria: History of prior MAb therapy History of prior treatment with an EGFR (HER-1) directed therapy Known brain metastases Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted) Known intercurrent infections or immunosuppression Actively infected with, or chronic carriers of HBV Evidence of HCV disease Previous diagnosis of autoimmune disease Known hypersensitivity to the administered drugs or any of their components Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 24, 2003
Last Updated
January 19, 2017
Sponsor
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT00073541
Brief Title
A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer
Official Title
An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
EMD Serono

4. Oversight

5. Study Description

Brief Summary
EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
EGFR; HER-1; monoclonal antibody; targeted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EMD 72000

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease Immunohistochemical evidence of tumor EGFR (HER-1) expression At least one measurable lesion according to the WHO criteria Life expectancy ≥ 12 weeks ECOG performance status 0-1 Exclusion Criteria: History of prior MAb therapy History of prior treatment with an EGFR (HER-1) directed therapy Known brain metastases Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted) Known intercurrent infections or immunosuppression Actively infected with, or chronic carriers of HBV Evidence of HCV disease Previous diagnosis of autoimmune disease Known hypersensitivity to the administered drugs or any of their components Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment
Facility Information:
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
New York
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17126894
Citation
Seiden MV, Burris HA, Matulonis U, Hall JB, Armstrong DK, Speyer J, Weber JD, Muggia F. A phase II trial of EMD72000 (matuzumab), a humanized anti-EGFR monoclonal antibody, in patients with platinum-resistant ovarian and primary peritoneal malignancies. Gynecol Oncol. 2007 Mar;104(3):727-31. doi: 10.1016/j.ygyno.2006.10.019. Epub 2006 Nov 28.
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A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

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