Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment gemcitabine and abraxane
Phase phase 2
Sponsor Georgetown University
Start date September 2014
End date December 2016
Trial size 4 participants
Trial identifier NCT02242409, LCCC 2013-0138

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gemcitabine and Abraxane
gemcitabine and abraxane Gemzar
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Primary Outcomes

Measure
4 month progression free survival
time frame: 2.5 years

Secondary Outcomes

Measure
Disease control rate
time frame: 2.5 years
Progression Free Survival
time frame: 2.5 years
Overall Survival
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
Principal investigator Michael Pishvaian, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Georgetown University.