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    View Dr. Argenta's presentation (PPT) View Dr. Argenta's presentation (PPT) Presentation Transcript

    • Current Ovarian Cancer Protocols Peter Argenta MD Division of Gynecologic Oncology Department of Obstetrics and Gynecology University of Minnesota
    • Trial Types
      • Therapeutic
        • Phase I
        • Phase II
        • Phase III
        • Preventative/screening
      • Information Gathering
        • Discovery
        • Survivorship
          • Psychological
    • Current Trials in Ovarian Cancer
      • NCI – 103 current trials available
        • Includes US, European, and international
        • Chemotherapy, Radiation, Surgical, Transplant
      • GOG – 14 active trials
        • 4 additional temporarily closed, 2 in development
      • University of Minnesota – 11 active trials
        • Mayo 7 active trials (3 non-overlapping)
    • Phase I
      • NCI – 36 Current Phase I trials
      • GOG – 2
        • CT-2103 + Carboplatin – 1 st line
        • Radiation potentiation of Docetaxel – 2 nd line
      • UM –2
        • Continuous infusion Docetaxel
        • Weekly Topotecan
    • Phase II
      • NCI – 45 Current Phase II trials
      • GOG – 7
        • 126 series - Platinum-resistant series
          • 126P – Weekly Taxol+Celebrex
          • 126Q – Premetrexed (Altima)
        • 146 series – Platinum sensitive
          • 146N – PS-341 single agent
          • 146O- Irofulven single agent
          • 146P – Carboplatin + Cetuximab
          • 170F – BAY43-9006
        • 9910 P53 vaccination trial
    • Phase II
      • University of Minnesota –3
        • WCC31 – Topotecan+/- thalidomide
        • Biweekly caboplatin + gemcitabine
        • Pegfilgrastim during chemotherapy
      • Mayo –1
        • Thalidomide
    • Phase III
      • NCI – 13 Current Phase III
      • GOG –2+
        • GOG 182 – 5 arm doublets and triplets – CLOSED
        • GOG 175 – T/C x3 vs. T/C x3 + consolidation in early disease
        • GOG 198 – Tamoxifen vs. Thalidomide in chemical recurrences
    • Prevention
      • NCI+GOG=UM=Mayo = 2
        • GOG-190 Fenretinide
        • GOG-199 Risk-reducing surgery
    • Screening
      • NCI – 7 protocols
        • 6 for high risk patients only
        • 1 for general population
          • Most are CA-125 =/- Ultrasound
    • Discovery
      • NCI - ?
      • GOG – subset of many
      • U of MN – 1+
        • MCP-1 in newly diagnosed cancers
        • Drug sensitivity assay under development
    • Survivorship
      • NCI – 10 protocol
      • GOG – No open protocols
      • U of MN – 4
        • Neuropathy reduction using atexakin- 
        • Outcomes of patients using CAM
        • Urinary incontinence Survey
        • Whole foods trial and survey
      • Mayo – 2
        • Experience of partners of patients
        • Spiritual well-being and overall QOL
    • Directions
      • WWII until 1990’s –  toxicity =  efficacy
      • 1990’s-2000 – Modified drugs or dosing results in decreased toxicity – small change in prognosis
      • 2000+
        • Biologic response modifiers
        • Alternate dosing regimens
        • Patient/tumor directed therapy
        • Prevention
    • Clinical Trials – What takes so long?
      • Discovery
      • Development
        • Cost – 2004 > $1,000,000,000.00
          • Liability
          • Utility
      • Enrollment
        • Patient heterogeneity, fears, desires
      • Analysis – Time to event
        • Bias
        • Chance
    • Solution
      • COLLABORATION!
        • Patients
        • Doctors
        • Researchers
        • Industry
        • Government