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

This study is ongoing, but not recruiting participants.

Sponsored by: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004176
  Purpose

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.


Condition Intervention Phase
Drug/Agent Toxicity by Tissue/Organ
Lung Cancer
Radiation Toxicity
Drug: amifostine trihydrate
Drug: cisplatin
Drug: etoposide
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Etoposide    Cisplatin    Etoposide phosphate    Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   33
Study Start Date:   August 1998

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004176

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

Sponsors and Collaborators
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Investigators
Study Chair:     Todd H. Wasserman, MD     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067202, WU-98-0206, ALZA-WU-98-0206, NCI-V99-1559
First Received:   January 21, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004176
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer  
drug/agent toxicity by tissue/organ  
radiation toxicity  

Study placed in the following topic categories:
Thoracic Neoplasms
Amifostine
Esophageal disorder
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Esophageal Diseases
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Radiation-Protective Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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