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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073541
• Other study ID #: EMD 72000-030
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2003
• Last updated: January 19, 2017
• Start date: April 2003
• Est. completion date: August 2004

Study information

• Verified date: January 2017
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• EMD 72000

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. G — View Citation