Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); etoposide (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Official(s) and/or principal investigator(s):
Todd H. Wasserman, MD, Study Chair, Affiliation: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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.
Clinical Details
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
Study design: Supportive Care
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Rocky Mountain Cancer Center, Denver, Colorado 80218, United States
Washington University Barnard Cancer Center, Saint Louis, Missouri 63110, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1998
Last updated: June 17, 2008
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