None listed
Conditions
Brief 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.
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
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.
Sponsors
Southern Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2. Locally advanced disease not amenable to curative surgery. 3. Patients should have a projected life expectancy of at least 6 weeks 4. Complete recovery from prior surgery 5. ECOG performance status (less than or equal to) 2 6. Male or female, eighteen years or older 7. Measurable disease as defined by RECIST 1.1. 8. A glomerular filtration rate (GFR) (greater than or equal to) 60 mL/min as measured by TcDTPA scan or Cockroft-Gault equation 9. Serum bilirubin < 30 umol/L 10. Adequate bone marrow function, WBC > 3 x 10^9/L, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L 11. Written informed consent
Exclusion criteria
1. Metastatic disease from pancreatic cancer 2. Prior chemotherapy 3. History of other malignant diseases other than non-melanomatous skin cancer or in-situ carcinoma of the uterine cervix 4. Clinical evidence of uncontrolled angina pectoris, cardiac failure, clinically significant cardiac arrhythmia, or other serious uncontrolled medical condition 5. Pregnant or lactating (any woman of childbearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment) 6. Peripheral neuropathy greater than CTCAE Grade 2. 7. Hepatitis B positive (positive HBsAg / HBeAg)
Outcome results
None listed