Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors|
- Dose Limiting Toxicity (DLT) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
- Maximum Tolerated Dose(MTD) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD
- Radiographic Response to Treatment [ Time Frame: every 42 days ] [ Designated as safety issue: No ]Radiographic response will be measured and evaluated using RECIST criteria.
|Study Start Date:||August 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Drug: gemcitabine hydrochloride
- 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 formulation (Abraxane).
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.
|United States, North Carolina|
|University of North Carolina Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Thomas E. Stinchcombe, MD||UNC Lineberger Comprehensive Cancer Center|