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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132522
• Other study ID #: EMR 62206-015
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2005
• Last updated: October 23, 2013
• Start date: May 2005
• Est. completion date: April 2009

Study information

• Verified date: October 2013
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-small-cell Lung
• Colorectal Cancer
• Ovarian Cancer
• Prostate Cancer

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy		various timepoints	No
Primary	safety		various timepoints	Yes