Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with progressive adenocarcinoma of the lung.
Adenocarcinoma of the Lung
|Study Design:||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|
- 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 ]
- Tumor responses to EC145 therapy [ Time Frame: Duration of EC145 therapy will vary according to individual participant 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 ]
|Study Start Date:||August 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
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
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.