Back to resultsEMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
Primary Purpose
Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EMD 273066
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring EpCAM, monoclonal-antibody, targeted therapy, colorectal, prostate, non-small cell lung cancer, ovarian, solid tumor
Eligibility 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
Sites / Locations
- City of Hope
- Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
- Fox Chase Cancer Oncology Department of Medical Oncology
- University of Wisconsin Division of Gynecologic Oncology
- Centre pluridisciplinaire d'Oncologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
efficacy
safety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132522
Brief Title
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung, Prostate Cancer
Keywords
EpCAM, monoclonal-antibody, targeted therapy, colorectal, prostate, non-small cell lung cancer, ovarian, solid tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EMD 273066
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy
Time Frame
various timepoints
Title
safety
Time Frame
various timepoints
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph O'Connor, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Durate
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Fox Chase Cancer Oncology Department of Medical Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Wisconsin Division of Gynecologic Oncology
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Centre pluridisciplinaire d'Oncologie
City
Lausanne
State/Province
Rue du Bugnon
ZIP/Postal Code
46
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23320927
Citation
Connor JP, Cristea MC, Lewis NL, Lewis LD, Komarnitsky PB, Mattiacci MR, Felder M, Stewart S, Harter J, Henslee-Downey J, Kramer D, Neugebauer R, Stupp R. A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors. BMC Cancer. 2013 Jan 15;13:20. doi: 10.1186/1471-2407-13-20.
Results Reference
derived
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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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