Study of Gemcitabine and Abraxane for Pancreas Cancer

February 13, 2017 updated by: Georgetown University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Lombardi Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine/abraxane
Gemcitabine and Abraxane
Drug: Gemcitabine and Abraxane
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Other Names:
  • Gemzar
  • Nab-paclitaxel
  • nanoparticle-bound paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4 month progression free survival
Time Frame: 2.5 years
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
Time Frame: 2.5 years
Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria
2.5 years
Progression Free Survival
Time Frame: 2.5 years
The time in days from study entry until progression or death
2.5 years
Overall Survival
Time Frame: 3 years
The time in days from study entry until death
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 2013-0138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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