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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00004176
First received: January 21, 2000
Last updated: May 14, 2013
Last verified: May 2013
  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
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 34
Study Start Date: October 1998
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Washington University School of Medicine
Investigators
Study Chair: William H. Read, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00004176     History of Changes
Other Study ID Numbers: CDR0000067202, WU-98-0206, ALZA-WU-98-0206, NCI-V99-1559
Study First Received: January 21, 2000
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
limited stage small cell lung cancer
drug/agent toxicity by tissue/organ
radiation toxicity

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Radiation Injuries
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Wounds and Injuries
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014