Platinum Resistant Ovarian Cancer Evaluation of Doxil and Vintafolide (MK-8109, EC145) Combination Therapy (8109-009, EC-FV-04)

PHASE2CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

December 31, 2012

Conditions
Ovarian Cancer
Interventions
DRUG

Vintafolide

2.5 mg IV bolus on Days 1,3,5 and 15,17,19 of a 4-week cycle

DRUG

pegylated liposomal doxorubicin (PLD)

50 mg/m\^2 (with dose based on ideal body weight for participants whose measured body weight is greater than their ideal body weight) intravenous infusion on Day 1 of a 4 week cycle. Dose reductions permitted for toxicity.

OTHER

EC20

During the screening period, participants at centers with EC20 imaging capability will receive a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure. A second injection and imaging may be done after all therapy with the study drugs is done.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endocyte

INDUSTRY