Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003583|
Recruitment Status : Unknown
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 30, 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. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Lung Cancer Radiation Toxicity||Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Evaluate the reduction in toxicities by combining amifostine with cisplatin, etoposide, and radiotherapy in patients with limited stage small cell lung cancer. II. Evaluate the response rate to this combination by these patients. III. Evaluate the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cisplatin IV on day 1 and etoposide IV daily on days 1-3. This course is repeated every 3 weeks for a total for 4 courses. Patients also receive concurrent radiotherapy 5 days per week for 5.5 weeks starting with the first course of chemotherapy. Patients receive amifostine IV over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3. Patients are followed at 6 and 12 weeks, then every 3 months for 9 months, every 6 months for 1 year, and then until death.
PROJECTED ACCRUAL: There will be 20 patients accrued into this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer|
|Study Start Date :||June 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): NCT00003583
|United States, Florida|
|University of Florida - Gainesville|
|Gainesville, Florida, United States, 32610-0277|
|Study Chair:||Dean L. McCarley, MD||Veterans Affairs Medical Center - Gainesville|