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

Primary Purpose

Adenocarcinoma of the Lung

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Vintafolide

Etarfolatide

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Lung focused on measuring Cancer, Adenocarcinoma, Phase II, Lung, Non-small cell lung cancer, NSCLC, EC145, EC20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etarfolatide + Vintafolide

Arm 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.

Outcomes

Primary Outcome Measures

Percentage of patients deriving clinical benefit

Secondary Outcome Measures

Tumor responses to EC145 therapy

Progression-free survival, response duration, and overall survival time observed after EC145 therapy

Full Information

NCT ID

NCT00511485

First Posted

August 2, 2007

Last Updated

February 9, 2015

Sponsor

Endocyte

1. Study Identification

Unique Protocol Identification Number

NCT00511485

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endocyte

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Lung

Keywords

Cancer, Adenocarcinoma, Phase II, Lung, Non-small cell lung cancer, NSCLC, EC145, EC20

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etarfolatide + Vintafolide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vintafolide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Etarfolatide

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Tumor responses to EC145 therapy

Time Frame

Duration of EC145 therapy will vary according to individual participant response.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Binh Nguyen, MD, PhD

Organizational Affiliation

Endocyte

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

17483358

Citation

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. doi: 10.1158/0008-5472.CAN-07-0033.

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

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