Ovarian Cancer Clinical Trial
Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
Summary
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Full Description
Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD
is safe, or
to assess the potential drug-drug interaction, and
to prolong response to chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of epithelial ovarian cancer
Must have measurable disease by CT or MRI scan
Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
Must have been treated with surgery and be a candidate for repeat carboplatin therapy
Must have a normal cardiac ejection fraction at baseline
Exclusion Criteria:
Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy
Subjects who have received other therapy to treat their ovarian cancer since last relapse
Known central nervous system tumor involvement
Evidence of other active invasive malignancy
Clinically significant heart disease
Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
Previous treatment with MORAb 003 (farletuzumab)
Previous treatment with anthracyclines
Clinical contraindications to use PLD
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There are 5 Locations for this study
Birmingham Alabama, 35293, United States
Baltimore Maryland, 21205, United States
Brightwaters New York, 11718, United States
Chattanooga Tennessee, 37403, United States
Harlingen Texas, 78550, United States
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