Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003555
- Lead Sponsor
- State University of New York - Upstate Medical University
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with amifostine in treating patients with recurrent or refractory solid tumors.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel following amifostine in patients with recurrent or refractory solid tumors. II. Assess tumor response rate and survival in these patients.
OUTLINE: This is a dose escalation study of paclitaxel. Patients receive amifostine IV over 5 minutes or less on day 0, followed by paclitaxel IV over 1 hour once a week for 6 weeks followed by 2 weeks of rest. Patients with complete or partial response may receive additional courses of therapy. Cohorts of 3-5 patients each receive increasing doses of paclitaxel. The maximum tolerated dose is defined as the dose level prior to the cohort at which 1 of 3-5 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States