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

Sponsors and Collaborators:	EMD Pharmaceuticals Merck KGaA
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00132522

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Colorectal Cancer Carcinoma, Non-Small-Cell Lung Prostate Cancer	Drug: EMD 273066	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer Lung Cancer Ovarian Cancer Prostate Cancer

Drug Information available for: Cyclophosphamide Immunoglobulins Globulin, Immune Tucotuzumab celmoleukin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Study to Find the Highest Dose of Biological Study Drug (EMR 273066) That Can Be Given Safely to Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-Small Cell Lung Cancers When First Given a Low Dose of Cyclophosphamide

Further study details as provided by EMD Pharmaceuticals:

Primary Outcome Measures:

efficacy [ Time Frame: various timepoints ] [ Designated as safety issue: No ]
safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2004
Estimated Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: EMD 273066 dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product. Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2.

Arms

Assigned Interventions

Arm 1: Experimental

Drug: EMD 273066

dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product.

Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132522

Locations

United States, California
City of Hope
Durate, California, United States, 91010
United States, New Hampshire
Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Fox Chase Cancer Oncology Department of Medical Oncology
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
University of Wisconsin Division of Gynecologic Oncology
Madison, Wisconsin, United States, 53792
Switzerland, Rue du Bugnon
Centre pluridisciplinaire d'Oncologie
Lausanne, Rue du Bugnon, Switzerland, 46

Sponsors and Collaborators

EMD Pharmaceuticals

Merck KGaA

Investigators

Principal Investigator:

Joseph O'Connor, MD

University of Wisconsin, Madison

More Information

Responsible Party:	Merck KGaA ( Marie-Louice Willberg )
Study ID Numbers:	EMR 62206-015
Study First Received:	August 19, 2005
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00132522
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Pharmaceuticals:

EpCAM
monoclonal-antibody
targeted therapy
colorectal

prostate
non-small cell lung cancer
ovarian
solid tumor

Study placed in the following topic categories:

Thoracic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Cyclophosphamide
Ovarian Diseases
Rectal Diseases
Antibodies, Monoclonal
Genital Diseases, Female
Respiratory Tract Diseases
Lung Neoplasms
Immunoglobulins

Endocrine Gland Neoplasms
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms
Recurrence
Carcinoma
Antibodies
Digestive System Diseases
Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009