Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Drug/Agent Toxicity by Tissue/Organ; Radiation Toxicity; Lung Cancer

• Registration Number: NCT00004176
• Lead Sponsor: Washington University School of Medicine

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. 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 plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the incidence and duration of moderate and severe acute esophagitis in patients with limited stage small cell lung cancer treated with amifostine chemoprotection plus chemotherapy and radiotherapy. II. Determine the tumor response to this regimen in these patients.

OUTLINE: Course 1: Patients receive amifostine IV over 5 minutes daily, followed by radiotherapy twice daily Monday through Friday for 3 weeks. Patients receive cisplatin IV over 30-60 minutes on day 1, and etoposide IV over 1 hour on days 1, 2, and 3. Courses 2-4: Patients receive amifostine over 15 minutes on day 1, followed by cisplatin IV over 30-60 minutes and etoposide IV over 1 hour every 3 weeks. Patients are followed at 1 month, then every 3 months until death.

PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 1-2 years.

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2000-01-21
• Primary Completion: 2001-02
• Study Completion: 2001-02
• Study First Submitted QC: 2004-05-24
• Study First Posted: 2004-05-25
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

Washington University Barnard Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States