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Sponsored by: |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004176 |
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 |
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Cancer-Related Problem/Condition Lung Cancer |
Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Radiation: radiation therapy |
Phase II |
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 |
Estimated Enrollment: | 33 |
Study Start Date: | August 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
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 |
Study Chair: | Todd H. Wasserman, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000067202, WU-98-0206, ALZA-WU-98-0206, NCI-V99-1559 |
Study First Received: | January 21, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004176 History of Changes |
Health Authority: | United States: Federal Government |
limited stage small cell lung cancer drug/agent toxicity by tissue/organ radiation toxicity |
Thoracic Neoplasms Radiation-Protective Agents Amifostine Carcinoma, Neuroendocrine Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Cisplatin |
Respiratory Tract Diseases Esophageal Disorder Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Esophageal Diseases Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms by Histologic Type Amifostine Carcinoma, Neuroendocrine Physiological Effects of Drugs Neoplasms, Nerve Tissue Protective Agents Pharmacologic Actions Carcinoma |
Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Glandular and Epithelial |