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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132522

Enrollment

Registered

2005-08-22

Start date

2005-05-31

Completion date

2009-04-30

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

EpCAM, monoclonal-antibody, targeted therapy, colorectal, prostate, non-small cell lung cancer, ovarian, solid tumor

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.

Interventions

DRUGEMD 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
efficacy	various timepoints
safety	various timepoints

Countries

Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026