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

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ClinicalTrials.gov Identifier: NCT00132522
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Colorectal Cancer Carcinoma, Non-small-cell Lung Prostate Cancer Drug: EMD 273066 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Find the Highest Dose of Biological Study Drug (EMD 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
Study Start Date : May 2005
Primary Completion Date : June 2008
Study Completion Date : April 2009


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 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.



Outcome Measures

Primary Outcome Measures :
  1. efficacy [ Time Frame: various timepoints ]
  2. safety [ Time Frame: various timepoints ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centre pluridisciplinaire d'Oncologie
Lausanne, Rue du Bugnon, Switzerland, 46
Sponsors and Collaborators
EMD Serono
Investigators
Principal Investigator: Joseph O'Connor, MD University of Wisconsin, Madison
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00132522     History of Changes
Other Study ID Numbers: EMR 62206-015
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by EMD Serono:
EpCAM
monoclonal-antibody
targeted therapy
colorectal
prostate
non-small cell lung cancer
ovarian
solid tumor

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cyclophosphamide
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists