Study of Gemcitabine and Abraxane for Pancreas Cancer

Georgetown University

Status and phase

Terminated

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine and Abraxane

Study type

Interventional

Funder types

Other

Identifiers

NCT02242409

LCCC 2013-0138

Details and patient eligibility

About

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

Full 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 cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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