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NCT Number: NCT00073541

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMD 72000

Drug

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Nov 26, 2003
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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