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 Network0 个研究点目标入组 15 人开始时间: 2013年9月11日最近更新: 2020年1月13日

试验速览

暂无简介。

•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

•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)

发起方

Southern Adelaide Local Health Network