Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511485
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):

Brief Summary:
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with progressive adenocarcinoma of the lung.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Lung Drug: Vintafolide Drug: Etarfolatide Phase 2

Detailed Description:

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

Vintafolide 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 vintafolide is generally well-tolerated, without many of the side-effects observed in more-standard therapeutic agents. This evidence suggests that vintafolide 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 vintafolide .

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

Information about the safety and tolerability of both vintafolide and etarfolatide will be assessed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Etarfolatide + Vintafolide
Screening: After completion of all screening procedures and confirmation of eligibility, all participants receive a 1- to 2-mL injection of 0.1 mg etarfolatide labeled with 20 to 25 mCi of technetium-99m. Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) computed tomography (CT), participant may proceed into maintenance phase. Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Participants continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined clinical benefit.
Drug: Vintafolide
Induction: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: vintafolide 2.5 mg intravenous injection, Monday, Wednesday, and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

Drug: Etarfolatide

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Tumor responses to EC145 therapy [ Time Frame: Duration of EC145 therapy will vary according to individual participant response. ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced, progressive, adenocarcinoma of the lung.
  • Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can include an epidermal growth factor receptor [EGFR] inhibitor). There is no upper limit to the number of prior chemotherapeutic regimens.
  • Eastern Cooperative Oncology Group (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 ertafolide "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.
  • Participants requiring palliative radiotherapy at time of study entry.

Note: Participants with central nervous system (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, participants must be off steroids and/or antiseizure medications for at least 14 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511485

Sponsors and Collaborators
Study Director: Binh Nguyen, MD, PhD Endocyte

Responsible Party: Endocyte Identifier: NCT00511485     History of Changes
Other Study ID Numbers: 8109-008
EC-FV-03 ( Other Identifier: Endocyte )
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by Endocyte:
Phase II
Non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Folic Acid
Vinca Alkaloids
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action