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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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EMD 72000

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No