Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
- Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel
albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine
hydrochloride in patients with advanced metastatic solid tumors.
- Evaluate the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) IV over
30 minutes on day 1 followed by gemcitabine hydrochloride IV over 30 minutes on days 1 and
8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized
nanoparticle formulation (Abraxane) until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Up to 10 additional patients may be treated at the MTD.
After completion of study treatment, patients are followed at 30 days.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity (DLT)
Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
Thomas E. Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|University of North Carolina Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|