Clinical trial NCT00132522: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: efficacy
timeFrame: various timepoints
measure: safety
timeFrame: various timepoints
Secondary outcomes:
Other outcomes:
Locations:
city: Durate
country: United States
facility: City of Hope
state: California
city: Lebanon
country: United States
facility: Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
state: New Hampshire
city: Philadelphia
country: United States
facility: Fox Chase Cancer Oncology Department of Medical Oncology
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin Division of Gynecologic Oncology
state: Wisconsin
city: Lausanne
country: Switzerland
facility: Centre pluridisciplinaire d'Oncologie
state: Rue du Bugnon
Study officials:
affiliation: University of Wisconsin, Madison
name: Joseph O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.