Phase I open label trial of Abraxane (nab-paclitaxel) administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma.
Southern Adelaide Local Health Network
15 participants
Sep 10, 2012
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
For each Cohort, on a weekly schedule (Day 1, 8, 15, 22, 29, 36) patients will receive a single dose of Abraxane (nab-paclitaxel) via intravenous infusion over 30 mins. These weekly doses will continue until maximum tolerated dose (MTD) is reached. The first dose on Day 1 is followed up concurrently 24 hours later with radiotherapy, which is fractionated daily (1.8 Gy daily dose) from Day 2-5, Day 8-12, Day 15-19, Day 22-26, Day 29-33, Day 36-40, & Day 43. (5 fractions per week, 28 fractionated doses total), for up to 6 weeks only (if doses are tolerated). Cohort 1: 25 mg/m2 - weekly dose / 6 weeks. Cohort 2: 50 mg/m2 - weekly dose / 6 weeks. Cohort 3: 75 mg/m2 - weekly dose / 6 weeks. Cohort 4: 100 mg/m2 - weekly dose / 6 weeks.
Locations(3)
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ACTRN12613001013752