EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide

Phase 1

Completed

• Conditions: Colorectal Cancer; Ovarian Cancer; Carcinoma, Non-small-cell Lung; Prostate Cancer
• Interventions: Drug: EMD 273066

• Registration Number: NCT00132522
• Lead Sponsor: EMD Serono

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, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Primary Completion: 2008-06
• Study Completion: 2009-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	EMD 273066	-

Primary Outcome Measures

Name	Time	Method
efficacy	various timepoints
safety	various timepoints

Trial Locations

Locations (5)

Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine; 🇺🇸 Lebanon, New Hampshire, United States

Fox Chase Cancer Oncology Department of Medical Oncology; 🇺🇸 Philadelphia, Pennsylvania, United States

City of Hope; 🇺🇸 Durate, California, United States

Centre pluridisciplinaire d'Oncologie; 🇨🇭 Lausanne, Rue du Bugnon, Switzerland

University of Wisconsin Division of Gynecologic Oncology; 🇺🇸 Madison, Wisconsin, United States