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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Radiation Toxicity

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William H. Read, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

CDR0000067202

NCT ID:

NCT00004176

Start Date:

October 1998

Completion Date:

February 2001

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Radiation Toxicity
  • limited stage small cell lung cancer
  • drug/agent toxicity by tissue/organ
  • radiation toxicity
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Injuries

Name

Location

Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Rocky Mountain Cancer CenterDenver, Colorado  80218