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

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Brief Title

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

Official Title

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

Brief Summary

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

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of patients deriving clinical benefit

Secondary Outcome

 Tumor responses to EC145 therapy

Condition

Adenocarcinoma of the Lung

Intervention

Vintafolide

Study Arms / Comparison Groups

 Etarfolatide + Vintafolide
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

August 2007

Completion Date

November 2009

Primary Completion Date

July 2009

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Binh Nguyen, MD, PhD, , 



Administrative Informations


NCT ID

NCT00511485

Organization ID

8109-008

Secondary IDs

EC-FV-03

Responsible Party

Sponsor

Study Sponsor

Endocyte


Study Sponsor

Binh Nguyen, MD, PhD, Study Director, Endocyte


Verification Date

February 2015