RecruitingACTRN12613001013752

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


Sponsor

Southern Adelaide Local Health Network

Enrollment

15 participants

Start Date

Sep 10, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy drug called Abraxane (nab-paclitaxel) given at the same time as radiotherapy in patients with locally advanced pancreatic cancer that cannot be surgically removed. Pancreatic cancer is very difficult to treat, and combining chemotherapy with radiation may work better than either alone. This early-phase study aims to find the highest safe dose of Abraxane that can be given alongside radiotherapy over 6 weeks. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with adenocarcinoma of the pancreas that cannot be removed by surgery - Your cancer has not spread to distant parts of the body (no metastases) - You are in reasonably good health (ECOG performance status 0–2) - You have not had prior chemotherapy for this cancer - You are male or female You may NOT be eligible if: - Your cancer has already spread to other organs (metastatic disease) - You have previously received chemotherapy - You have another active cancer (except minor skin cancers) - You have serious heart problems or uncontrolled medical conditions - You are pregnant or breastfeeding - You have significant nerve damage (neuropathy) or hepatitis B Talk to your doctor about whether this trial might be right for you.

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 continu

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)

Flinders Medical Centre - Bedford Park

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12613001013752