Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung - Full Text View

Sponsor:	Endocyte
Information provided by:	Endocyte
ClinicalTrials.gov Identifier:	NCT00511485

Purpose

This is a Phase II clinical trial evaluating the benefit from therapy with EC145 in patients with progressive adenocarcinoma of the lung.

Condition	Intervention	Phase
Adenocarcinoma of the Lung	Drug: EC145	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Endocyte:

Primary Outcome Measures:

Percentage of patients deriving clinical benefit. [ Time Frame: Clinical benefit is defined as the ability to receive 4 or more cycles (i.e. months) of therapy without progression of disease. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor responses to EC145 therapy. [ Time Frame: Duration of EC145 therapy will vary according to individual patient response. ] [ Designated as safety issue: No ]
Progression-free survival, response duration, and overall survival time observed after EC145 therapy. [ Time Frame: 2 years after completing therapy with EC145 and the 30-day follow-up period. ] [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2011
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) CT, patient may proceed into maintenance phase. Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Patients continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined maximum benefit.	Drug: EC145 Induction: EC145 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: EC145 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, patients may receive EC145 via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

Arms

Assigned Interventions

Experimental: 1

Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) CT, patient may proceed into maintenance phase.

Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Patients continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined maximum benefit.

Drug: EC145

Induction: EC145 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle.

Maintenance: EC145 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle.

At the investigator's discretion, patients may receive EC145 via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

Detailed Description:

This is a Phase II clinical trial of EC145 administered to patients with progressive adenocarcinoma of the lung.

EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on a significant portion of non-small cell lung cancers. Early clinical evidence in a small number of Phase I patients suggests that EC145 is generally well-tolerated, without many of the side-effects observed in more-standard therapeutic agents. This evidence suggests that EC145 may be useful as a chemotherapy against progressive adenocarcinomas of the lung. The primary objective of this study is to collect data on clinical benefit produced by therapy with EC145.

All patients will undergo imaging with the FR targeting investigational imaging agent EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial. Clinical evidence suggests that EC20 may be used to identify patients with cancers that express the target receptor.

Information about the safety and tolerability of both EC145 and EC20 will be assessed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced, progressive, adenocarcinoma of the lung.
Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can include an EGFR inhibitor). There is no upper limit to the number of prior chemotherapeutic regimens.
ECOG performance status of 0-2.
At least 4 weeks from prior therapy and recovered from associated acute toxicities.
Radiographic evidence of measurable disease and EC20 "positive" tumor.
Adequate bone marrow reserve, hepatic, and renal function.
Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods.

Exclusion Criteria:

Serious comorbidities (as determined by the Principal Investigator).
History of carcinomatous peritonitis.
History of severe bowel obstruction (as determined by the Principal Investigator).
Women who are pregnant or lactating.
Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site.
Patients requiring palliative radiotherapy at time of study entry.

Note: Patients with CNS metastasis are eligible if a) they have been treated for the CNS metastasis and have been clinically stable (with regard to their CNS disease) for >4 weeks and b) they do not require steroids or antiseizure medications (i.e., for seizure control), or if the CNS metastasis has been untreated to date, it is not associated with a midline shift or significant edema and there is no clinically-evident requirement for steroids or antiseizure medication. In either situation, patients must be off steroids and/or antiseizure medications for at least 14 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511485

Locations

United States, California
Central Hematology Oncology Medical Group, INC
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
UCLA Division of Hematology-Oncology
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91325
Ventura County Hematology-Oncology
Oxnard, California, United States, 93030
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Division of Hematology/Oncology Research
Chicago, Illinois, United States, 60612
United States, Indiana
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Center for Blood and Cancer Disorders
Bethesda, Maryland, United States, 20817
United States, Michigan
Great Lakes Cancer Institute MSU
Lansing, Michigan, United States, 48910
Providence Cancer Institute
Southfield, Michigan, United States, 48075
United States, Missouri
Washington University Medical School
St. Louis, Missouri, United States, 63110
United States, North Carolina
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28277
United States, Pennsylvania
Donald Guthrie Foundation for Education and Research Clinical Research
Sayre, Pennsylvania, United States, 18840
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77031
United States, West Virginia
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Endocyte

Investigators

Study Director:	Richard A Messmann, MD, MHS, MSc	Endocyte
Principal Investigator:	Martin J Edelman, MD	University of Maryland Greenebaum Cancer Center

More Information

Additional Information:

EC145 Phase I Trial Results - Abstract 2007 ASCO Annual Meeting This link exits the ClinicalTrials.gov site

Publications:

Reddy JA, Dorton R, Westrick E, Dawson A, Smith T, Xu LC, Vetzel M, Kleindl P, Vlahov IR, Leamon CP. Preclinical evaluation of EC145, a folate-vinca alkaloid conjugate. Cancer Res. 2007 May 1;67(9):4434-42.

Responsible Party:	Richard Messmann, MD / Vice President Clinical Affairs, Endocyte, Inc.
ClinicalTrials.gov Identifier:	NCT00511485 History of Changes
Other Study ID Numbers:	EC-FV-03
Study First Received:	August 2, 2007
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endocyte:

Cancer
Adenocarcinoma
Phase II
Lung

Non-small cell lung cancer
NSCLC
EC145
EC20

Additional relevant MeSH terms:

Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012