Study of Gemcitabine and Abraxane for Pancreas Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02242409
• Other study ID #: LCCC 2013-0138
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2014
• Last updated: February 13, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 month progression free survival	The proportion of patients at 4 months from study entry with progression or death	2.5 years
Secondary	Disease control rate	Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria	2.5 years
Secondary	Progression Free Survival	The time in days from study entry until progression or death	2.5 years
Secondary	Overall Survival	The time in days from study entry until death	3 years