Status:
COMPLETED
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
Lead Sponsor:
EMD Serono
Conditions:
Ovarian Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostat...
Eligibility Criteria
Inclusion
- Recurrent non-small cell lung, colorectal, ovarian or prostate cancer
- No more than two lines of prior chemotherapy
- Positive EpCAM expression
- Karnofsky Performance Status \> 70%
- Adequate laboratory results
- Normal cardiac stress test
Exclusion
- Evidence of brain metastases
- Pregnant or lactating females
- Significant infection
- Prior receipt of EMD 273066
- Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration
- Uncontrolled hypertension
- Previous diagnosis of Addison's disease
- Previous diagnosis of an autoimmune disease
- Organ transplant
- Insulin-dependent diabetes
- History of acute pancreatitis
- Congestive heart failure
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00132522
Start Date
May 1 2005
End Date
April 1 2009
Last Update
October 25 2013
Active Locations (5)
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1
City of Hope
Durate, California, United States, 91010
2
Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
Lebanon, New Hampshire, United States, 03756
3
Fox Chase Cancer Oncology Department of Medical Oncology
Philadelphia, Pennsylvania, United States, 19111
4
University of Wisconsin Division of Gynecologic Oncology
Madison, Wisconsin, United States, 53792