Study of Gemcitabine and Abraxane for Pancreas Cancer

Phase 2TerminatedNCT02242409

Georgetown University4 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Gemcitabine and AbraxaneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Georgetown Lombardi Comprehensive Cancer Center

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

Outcomes

Primary Outcomes

4 month progression free survival

The proportion of patients at 4 months from study entry with progression or death

Time frame: 2.5 years

Secondary Outcomes

Disease control rate

Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria

Time frame: 2.5 years

Progression Free Survival

The time in days from study entry until progression or death

Time frame: 2.5 years

Overall Survival

The time in days from study entry until death

Time frame: 3 years

Data from ClinicalTrials.gov

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