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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004176
• Other study ID #: CDR0000067202
• Secondary ID: WU-98-0206ALZA-W
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: May 14, 2013
• Start date: October 1998
• Est. completion date: February 2001

Study information

• Verified date: May 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug/Agent Toxicity by Tissue/Organ
• Lung Cancer
• Lung Neoplasms
• Radiation Injuries
• Radiation Toxicity
• Small Cell Lung Carcinoma

Intervention

Drug:
• amifostine trihydrate

• cisplatin

• etoposide

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Washington University Barnard Cancer Center	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,