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  • ART in Lap

    Acronym: 

    ART in Lap

    ACTRN/NCT /ethics: 

    ACTRN12613001013752 Ethics: 132.12

    Scientific title: 

    Phase I open label trial of Abraxane (nab-paclitaxel) administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma.

    Summary of trial and patient characteristics

    Cancer Type Pancreas
    Trial Type Treatment
    Phase Phase I Tumour Stream Pancreas
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2013-09-09
    Molecular Target Anticipated End Date
    Cancer Type Pancreas
    Trial Type Treatment
    Phase Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Pancreas
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2013-09-09
    Anticipated End Date

    Trial Summary

    In this study we plan to evaluate the maximum tolerated dose (MTD) of the drug Abraxane, which can be safely given to patients concurrently with radiotherapy in locally advanced pancreatic cancer (LAPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with locally advanced adenocarcinoma of the pancreas, which is not amenable to curative surgery. Study details Participants in this study will receive the chemotherapy drug Abraxane (nab-paclitaxel) by intravenous infusion (i.e. directly into the vein) over 30 minutes on a weekly schedule, concurrently with radiotherapy for 6 weeks. The first participants will receive Abraxane at a dose of 25 mg/m2 and if this is tolerated the dose will be increased for the subsequent groups until the maximum tolerated dose can be determined. Participants will be regularly monitored for safety and tolerability throughout treatment. On completion of treatment they will also be followed up for up to 5 years in order to evaluate efficacy of treatment in terms of disease response and survival.

    Lay Summary

    Phase I open label trial of Abraxane (nab-paclitaxel) administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma.

    Sponsor / Cooperative group

    Sourthern Adelaide Local Health Network

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapedis Recruiting
    The Queen Elizabeth Hospital Sue Yeend Sue.Yeend@sa.gov.au 08 8222 6148 Recruiting
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 70742342 Singhal Recruiting