NCT00003130

Paclitaxel in Treating Women With Recurrent Solid Tumors

Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.

Detailed description

OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients. OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician. PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1997-11-01
• Primary completion: 2002-01-01
• Completion: 2006-01-01
• First posted: 2003-11-25
• Last updated: 2016-07-19

Locations

34 sites across 1 country: United States