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Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

2014-07-23 21:57:00 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Supportive Care

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

amifostine trihydrate, paclitaxel

Location

State University of New York - Upstate Medical University
Syracuse
New York
United States
13210

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:57:00-0400

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