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Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Lung

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Trial Information

Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Percentage of patients deriving clinical benefit.

Outcome Time Frame:

Clinical benefit is defined as the ability to receive 4 or more cycles (i.e. months) of therapy without progression of disease.

Safety Issue:


Principal Investigator

Richard A Messmann, MD, MHS, MSc

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

November 2011

Related Keywords:

  • Adenocarcinoma of the Lung
  • Cancer
  • Adenocarcinoma
  • Phase II
  • Lung
  • Non-small cell lung cancer
  • EC145
  • EC20
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Methodist Hospital Houston, Texas  77030
Blumenthal Cancer Center Charlotte, North Carolina  28203
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Cancer Care Associates Medical Group, Inc. Torrance, California  90505
Providence Cancer Institute Southfield, Michigan  48075
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Horizon Oncology Center Lafayette, Indiana  47905
Central Hematology Oncology Medical Group, Inc Alhambra, California  91801
Ventura County Hematology-Oncology Oxnard, California  93030
UCLA Division of Hematology-Oncology Los Angeles, California  90095
Division of Hematology/Oncology Research Chicago, Illinois  60612
Center for Blood and Cancer Disorders Bethesda, Maryland  20817
Great Lakes Cancer Institute MSU Lansing, Michigan  48910
Washington University Medical School St. Louis, Missouri  63110
Donald Guthrie Foundation for Education and Research Clinical Research Sayre, Pennsylvania  18840
West Virginia University Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506