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

NCT00722592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2015-01-07

No results posted yet for this study

Summary

The objective of this study is to compare progression-free survival (PFS), based upon investigator assessment using Response Evaluation Criteria In Solid Tumors version 1.0 (RECIST 1.0) and clinical findings, in participants with platinum-resistant ovarian cancer who receive combination therapy with vintafolide and pegylated liposomal doxorubicin (PLD/Doxil®/Caelyx®) with that in subjects with platinum-resistant ovarian cancer who receive PLD alone.

Conditions

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 & Collaborators

  • Endocyte

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30
Completion
2012-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00722592 on ClinicalTrials.gov