A Randomized Study of Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer
National Cancer Institute (NCI)
UT MD Anderson Cancer Center

      Multi-Phase study (I/II) that did not progress to Phase II of clinical trial, terminated
      early due to low accrual, separate ClinicalTrials.gov Registration NCT00102622 for Phase I of
      study:

      Phase I:

        -  Enrollment of up to 24 subjects in 8 cohorts of three subjects to one of three
           combinations of intraperitoneal (IP) tgDCC-E1A + intravenous (IV) paclitaxel by the
           continuous reassessment method (CRM) will be sufficient to establish the MTD

        -  The single agent paclitaxel cohort will consist of 24 subjects

      Phase II:

        -  Enrollment of up to 20 subjects to one of three combinations of IP tgDCC-E1A + IV
           paclitaxel decided by Phase I.

        -  The single-agent paclitaxel cohort will consist of 20 subjects.
    
Drug