NCT00095914

Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.

Detailed description

OBJECTIVES: Primary * Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel. Secondary * Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients. * Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients. * Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen. OUTLINE: This is a randomized, pilot study. * Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22. * Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22. * Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	paclitaxel
DRUG	paclitaxel albumin-stabilized nanoparticle formulation

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-05-01
• Completion: 2009-03-01
• First posted: 2004-11-09
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States