Status:
TERMINATED
Study of Gemcitabine and Abraxane for Pancreas Cancer
Lead Sponsor:
Georgetown University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
Detailed Description
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic c...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic adenocarcinoma of the pancreas
- Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
- Radiographically measurable or evaluable disease
- Age \>/= 18 years
- ECOG performance status 0-2
- Adequate hepatic, bone marrow and renal function
Exclusion
- Prior gemcitabine-based chemotherapy in the first line setting
- No active severe infection, or known chronic infection with HIV or hepatitis B virus
- No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
- Patients with known CNS metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
- Anticipated patient survival under 2 months
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02242409
Start Date
September 1 2014
End Date
December 1 2016
Last Update
February 14 2017
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007