Study of Gemcitabine and Abraxane for Pancreas Cancer

Study 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.

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

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine and Abraxane


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine/abraxane<br>Gemcitabine and Abraxane | Drug: Gemcitabine and Abraxane<br>* Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days<br>* Other names: Nab-paclitaxel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 month progression free survival | The proportion of patients at 4 months from study entry with progression or death | 2.5 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, Nab-paclitaxel