drugset / Trial / NCT00722592
Platinum Resistant Ovarian Cancer Evaluation of Doxil and Vintafolide (MK-8109, EC145) Combination Therapy (8109-009, EC-FV-04)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-09
- Primary completion
- 2010-09
- Completion
- 2012-12
Outcome
Met primary endpoint
paper Median PFS was 5.0 and 2.7 months for the vintafolide plus PLD and PLD-alone arms, respectively PMID 24127448 ↗
paper hazard ratio [HR], 0.63; 95% CI, 0.41 to 0.96; P = .031 PMID 24127448 ↗
Publications
- Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
- Naumann RW, Coleman RL, Burger RA, Sausville EA, Kutarska E, Ghamande SA, Gabrail NY, Depasquale SE, Nowara E, Gilbert L, Gersh RH, Teneriello MG, Harb WA, Konstantinopoulos PA, Penson RT, Symanowski JT, Lovejoy CD, Leamon CP, Morgenstern DE, Messmann RA. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2013 Dec 10;31(35):4400-6. doi: 10.1200/JCO.2013.49.7685. Epub 2013 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Vintafolide | Other / unclassified | 2.5 mg | Intravenous |