Study of Gemcitabine and Abraxane for Pancreas Cancer

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine and Abraxane

• Registration Number: NCT02242409
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/abraxane	Gemcitabine and Abraxane	Gemcitabine and Abraxane

Primary Outcome Measures

Name	Time	Method
4 month progression free survival	2.5 years	The proportion of patients at 4 months from study entry with progression or death

Secondary Outcome Measures

Name	Time	Method
Disease control rate	2.5 years	Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria
Progression Free Survival	2.5 years	The time in days from study entry until progression or death
Overall Survival	3 years	The time in days from study entry until death

Trial Locations

Locations (1)

Georgetown Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States