Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
- 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
- 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
After completion of study treatment, patients are followed every 3 months for 1 year and
then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival rate at 6 months
Overall survival will be measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
Overall survival will be measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause.
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|