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A Study to Assess Farletuzumabin Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Ovarian Cancer


Title A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus  Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer
Therapeutic Area Ovarian Cancer
Principal Investigator Young B. Kim, MD
Min Age 18 Years
Gender Female
Contact Jessika E Silva
617-636-8897
More Information http://clinicaltrials.gov/ct2/show/NCT02289950

Overview

This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.

Study Details

Inclusion Criteria

  • Subjects with ovarian cancer at first relapse with low CA125 and visible disease.
  • Relapse occurred between 6 months and 3 years of original platinum chemotherapy
  • Otherwise normal organ function

Exclusion Criteria

  • No other complicating malignancies such as heart disease active or an active infection
  • No known allergic reaction to monoclonal antibody therapies or previous treatment with Farletuzamab or cancer vaccine therapy
  • No pregnant or nursing women

Study Requirements

Participants will answer several questionnaires about their quality of life and their food and activity habits at the baseline visit, at 6 months after enrollment, at 12 months after enrollment, and at 2 years after enrollment. Participants will be contacted periodically by a life coach from The Unviersity of Arizona Cancer Center.