NCT00507741

Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)

Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Endocyte · Industry
• Sex: Female
• 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 advanced ovarian and endometrial cancers.

Detailed description

This is a Phase II clinical trial of vintafolide administered to participants with advanced ovarian and endometrial cancers. 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 virtually all ovarian cancers as well as the majority of endometrial cancers. Early clinical evidence in a small number of Phase I patients suggests that vintafolide may have antitumor effect in women with advanced ovarian cancer and that it is generally well-tolerated. This evidence suggests that vintafolide may be useful as chemotherapy against advanced ovarian and endometrial cancers. The primary objective of Part A of this study is to collect data on clinical benefit produced by therapy with vintafolide. The primary objective of Part B of this study is to collect data on the safety and efficacy of vintafolide. All participants will undergo imaging with the FR targeting investigational imaging agent ertafolide (EC20, FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial. Clinical evidence suggests that ertafolide may be used to identify women with cancers that express the target receptor. Information about the safety and tolerability of both vintafolide and ertafolide will be assessed.

Conditions

• Ovarian Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Vintafolide	Part A: Induction Phase: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance Phase: 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. Part B: 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	Ertafolide

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-07-26
• Last updated: 2015-01-07