Study of Gemcitabine and Abraxane for Pancreas Cancer

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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