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Study of Gemcitabine and Abraxane for Pancreas Cancer

Information source: Georgetown University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Gemcitabine and Abraxane (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Georgetown University

Official(s) and/or principal investigator(s):
Michael Pishvaian, MD PhD, Principal Investigator, Affiliation: Georgetown University

Overall contact:
Michael Pishvaian, MD PhD, Phone: 202-444-2198, Email: pishvaim@georgetown.edu

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 4 month progression free survival

Secondary outcome:

Disease control rate

Progression Free Survival

Overall Survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Michael Pishvaian, MD PhD, Phone: 202-444-2198, Email: pishvaim@georgetown.edu

Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia 20007, United States; Recruiting
Michael Pishvaian, MD PhD, Phone: 202-444-2198, Email: pishvaim@georgetown.edu
Lisa Ley, RN MSN, Phone: 202-687-6653, Email: leyl@georgetown.edu
Michael Pishvaian, MD PhD, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: April 14, 2015

Page last updated: August 20, 2015

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