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Docetaxel, Cisplatin, and Amifostine in Treating Patients With Advanced Non-Small Cell Lung Cancer

2014-08-27 03:58:19 | 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/II trial to study the effectiveness of combining docetaxel, cisplatin, and amifostine in treating patients who have advanced non-small cell lung cancer that cannot be surgically removed.

Description

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when combined with amifostine and high dose cisplatin in patients with advanced non-small cell lung cancer. II. Determine the response rate and survival of these patients treated with this regimen. III. Determine the tolerability of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of docetaxel. Patients receive amifostine IV over 15 minutes, immediately followed by docetaxel IV over 1 hour, followed at hour 2 by amifostine as above, immediately followed by high dose cisplatin IV over 30 minutes. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of patients receive escalating doses of docetaxel until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Drug/Agent Toxicity by Tissue/Organ

Intervention

amifostine trihydrate, cisplatin, docetaxel

Location

University of Wisconsin Comprehensive Cancer Center
Madison
Wisconsin
United States
53792

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:19-0400

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Medical and Biotech [MESH] Definitions

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

The action of a drug that may affect the activity, metabolism, or toxicity of another drug.

Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.

An agent derived from licorice root. It is used for the treatment of digestive tract ulcers, especially in the stomach. Antidiuretic side effects are frequent, but otherwise the drug is low in toxicity.

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

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