A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer

Georgetown University1 site in 1 country4 target enrollmentSeptember 2014

ConditionsPancreatic Cancer

InterventionsGemcitabine and Abraxane

DrugsGemcitabine and Abraxane

Overview

Phase: Phase 2
Intervention: Gemcitabine and Abraxane
Conditions: Pancreatic Cancer
Sponsor: Georgetown University
Enrollment: 4
Locations: 1
Primary Endpoint: 4 month progression free survival
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Georgetown University

Responsible Party

Sponsor

Eligibility 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