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 rateProgression 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
|