Study of Gemcitabine and Abraxane for Pancreas Cancer

NCT ID: NCT02242409

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemcitabine/abraxane

Gemcitabine and Abraxane

Group Type EXPERIMENTAL

Gemcitabine and Abraxane

Intervention Type DRUG

Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Interventions

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Gemcitabine and Abraxane

Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Intervention Type DRUG

Other Intervention Names

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Gemzar nanoparticle-bound paclitaxel Nab-paclitaxel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Pishvaian, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC 2013-0138

Identifier Type: -

Identifier Source: org_study_id

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