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

Recruiting

• Conditions: Patients with locally advanced inoperable pancreatic adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12613001013752
• Lead Sponsor: Southern Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) of concurrent Abraxane (Registered Trademark) and external beam radiotherapy (EBRT) for inoperable locally advanced pancreatic cancer (LAPC).<br><br>When a dose-limiting toxicity is observed in any of the cohorts, up to three additional patients will be added to the cohort. If fewer than two of six patients in the cohort develop dose-limiting toxicity, escalation to the next cohort will proceed.<br>The maximum tolerated dose (MTD) will be the dose below highest dose level at which fewer than two of six patients experience dose-limiting toxicity. [Measured from Enrolment, until completion of Cohort 4 (dependent on limiting toxicities).]