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Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
OBJECTIVES: Primary * To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen. Secondary * To determine the safety and characterize the toxicity profile of this drug. * To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease. * To determine CA 19-9 response. * To determine progression-free survival. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore
Start Date
June 1, 2008
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2012
Last Updated
May 11, 2017
20
ACTUAL participants
Abraxane
DRUG
Lead Sponsor
University of Miami
NCT05053971
NCT04550494
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