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

A Phase II Evaluation of Ethyol as an Esophageal Mucosal Protectant in the Treatment of Limited Disease Small Cell Lung Cancer With Chemotherapy and Twice-Daily Radiation

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Radiation Toxicity; Drug/Agent Toxicity by Tissue/Organ
• Intervention / Treatment: Radiation: radiation therapy; Drug: amifostine trihydrate; Drug: etoposide; Drug: cisplatin

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Barnard Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer confined to one hemithorax Measurable disease No pleural effusion(s)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and alkaline phosphatase no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal (8.9-10.3 mg/dL) Cardiovascular: No history of congestive heart failure or myocardial infarction within the past 6 months No uncontrolled or unexplained rhythm disturbance or symptoms of unstable ischemic heart disease Other: Not pregnant Fertile patients must use effective contraception No prior or concurrent malignancy within the past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent infection No significant uncontrolled hyponatremia No other significant concurrent medical or psychiatric illness which would preclude compliance No antecedent hearing loss Afebrile for at least 3 days unless fever due to tumor or obstructive pneumonia

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No drugs that could potentiate nephrotoxicity of cisplatin (e.g., aminoglycosides or lithium)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: William H. Read, M.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 1998
• Primary Completion (Actual): February 1, 2001
• Study Completion (Actual): February 1, 2001

Study Registration Dates

• First Submitted: January 21, 2000
• First Submitted That Met QC Criteria: May 24, 2004
• First Posted (Estimate): May 25, 2004

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: limited stage small cell lung cancer; radiation toxicity; drug/agent toxicity by tissue/organ
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Radiation-Protective Agents; Etoposide; Cisplatin; Amifostine
• Other Study ID Numbers: CDR0000067202; WU-98-0206; ALZA-WU-98-0206; NCI-V99-1559