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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung, Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy

Outcome Time Frame:

various timepoints

Safety Issue:

No

Principal Investigator

Joseph O'Connor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

EMR 62206-015

NCT ID:

NCT00132522

Start Date:

May 2005

Completion Date:

April 2009

Related Keywords:

  • Ovarian Cancer
  • Colorectal Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Prostate Cancer
  • EpCAM
  • monoclonal-antibody
  • targeted therapy
  • colorectal
  • prostate
  • non-small cell lung cancer
  • ovarian
  • solid tumor
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

City of HopeDuarte, California  91010
Dartmouth Medical School, Pharmacology & Toxicology Dept. of MedicineLebanon, New Hampshire  03756
Fox Chase Cancer Oncology Department of Medical OncologyPhiladelphia, Pennsylvania  19111
University of Wisconsin Division of Gynecologic OncologyMadison, Wisconsin  53792