NCT00511485

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Endocyte · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Lung

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2007-08-06
• Last updated: 2015-02-27