Research and Clinical Trials

Brief Description: Compare progression-free survival (PFS- length of time disease has stabilized) based on CT scans/MRI in subjects with platinum-resistant (period of time between last platinum chemo regimen is given and disease progresion is less than 6 months) ovarian cancer who receive combination therapy with EC145 (Monday/Wednesday/Friday every other week) and Doxil (once every 28 days) with subjects who receive Placebo (Monday/Wednesday/Friday every other week) and Doxil (once every 28 days).
Who may be Eligible: Key Inclusion criteria: At least 18 years old; pathology confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; platinum-resistant disease (either disease responded after initial platinum therapy and then worsened within 6 months of last dose or responded to initial platinum therapy and then worsened during or within 6 months of completing a second platinum-containing therapy); measurable disease (at least 1 single lesion meaures at least 1cm on CT scan/MRI or if enlarged lymph nodes only- must measure at least 1.5 cm in the shortest length); previous platinum-based (cisplatin or carboplatin) therapy; adequate blood counts and kidney/liver function; Key exclusion criteria: No disease response to previous platinum based therapy; previous treatment with Doxil, recent abdominal surgery; concurrent cancer; concurrent treatment for ovarian cancer, concurrent treatment with methotrexate.
Speciality/Disorder: Gynecological Cancer
IRB Number: 00-00-00
Principal Investigator: Naumann, Wendell

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