Docetaxel, Cisplatin, and Amifostine in Treating Patients With Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00004264|
Recruitment Status : Unknown
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 26, 2004
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Lung Cancer||Drug: amifostine trihydrate Drug: cisplatin Drug: docetaxel||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer|
|Study Start Date :||July 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004264
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Joan H. Schiller, MD||University of Wisconsin, Madison|