Lung Cancer Clinical Trial
Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer.
Full Description
OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II. Evaluate the response rate and overall survival in these patients. III. Reduce the toxic effects of treatment to esophagus and lungs.
OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5. (Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20, then twice daily for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each radiation dose level. If one patient experiences nonhematologic dose limiting toxicity (DLT), 5 additional patients are treated at that level. If no further DLT occurs, escalation to the next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell carcinoma of the lung Limited disease (stage I-IIIb but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral hilar or contralateral supraclavicular involvement) No pericardial or pleural effusion on chest x-ray regardless of cytology Measurable or evaluable disease Tumor must be encompassed by limited radiation therapy fields without causing severe symptomatic pulmonary dysfunction
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic heart disease At least 6 months since prior myocardial infarction Pulmonary: See Disease Characteristics Forced expiratory volume at one second (FEV1) greater than 0.8 L No uncontrolled bronchospasm in unaffected lung Other: No other serious concurrent illness No prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other concurrent malignancy No history of uncontrolled psychiatric illness, severe head injury, chronic alcohol or drug abuse, or central nervous system disease Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior complete tumor resection
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There are 253 Locations for this study
Birmingham Alabama, 35294, United States
Huntsville Alabama, 35801, United States
Huntsville Alabama, 35801, United States
Mobile Alabama, 36688, United States
Montgomery Alabama, 36106, United States
Tuscallosa Alabama, 35401, United States
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85013, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Concord California, 94524, United States
Duarte California, 91010, United States
Fresno California, 93720, United States
Fresno California, 93720, United States
Glendale California, 91204, United States
Greenbrae California, 94904, United States
La Jolla California, 92093, United States
Loma Linda California, 92354, United States
Long Beach California, 90822, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Oakland California, 94609, United States
Pasadena California, 91105, United States
Pomona California, 91767, United States
Sacramento California, 95816, United States
San Diego California, 92101, United States
San Francisco California, 94143, United States
San Jose California, 95128, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80010, United States
Grand Junction Colorado, 81502, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20307, United States
Clearwater Florida, 33757, United States
Daytona Beach Florida, 32114, United States
Fort Myers Florida, 33901, United States
Gainesville Florida, 32610, United States
Melbourne Florida, 32901, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33125, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Orange Park Florida, 32073, United States
Orlando Florida, 32806, United States
Panama City Florida, 32401, United States
Panama City Florida, 32405, United States
Sarasota Florida, 34233, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Columbus Georgia, 31902, United States
Rome Georgia, 30165, United States
Honolulu Hawaii, 96813, United States
Arlington Heights Illinois, 60005, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Elgin Illinois, 60123, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61636, United States
Anderson Indiana, 46016, United States
Bloomington Indiana, 47402, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46206, United States
Indianapolis Indiana, 46219, United States
Muncie Indiana, 47303, United States
South Bend Indiana, 46601, United States
Dubuque Iowa, 52001, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40511, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40215, United States
Madisonville Kentucky, 42431, United States
Baton Rouge Louisiana, 70809, United States
Lafayette Louisiana, 70501, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Portland Maine, 04102, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21225, United States
Baltimore Maryland, 21225, United States
Baltimore Maryland, 21231, United States
Baltimore Maryland, 21237, United States
Salisbury Maryland, 21801, United States
Hyannis Massachusetts, 02601, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48432, United States
Flint Michigan, 48503, United States
Kalamazoo Michigan, 49007, United States
Marquette Michigan, 49855, United States
Midland Michigan, 48670, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Troy Michigan, 48098, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Tupelo Mississippi, 38801, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68105, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
East Orange New Jersey, 07018, United States
Edison New Jersey, 08818, United States
Elizabeth New Jersey, 07201, United States
Long Branch New Jersey, 07740, United States
Millville New Jersey, 08332, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 08901, United States
Newark New Jersey, 07112, United States
Pomona New Jersey, 08240, United States
Ridgewood New Jersey, 07450, United States
Toms River New Jersey, 08755, United States
Trenton New Jersey, 08629, United States
Warren New Jersey, 07059, United States
Albuquerque New Mexico, 87102, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Brooklyn New York, 11203, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14263, United States
Clifton Springs New York, 14432, United States
Manhasset New York, 11030, United States
New York New York, 10003, United States
New York New York, 10021, United States
New York New York, 10032, United States
Plattsburgh New York, 12901, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Syracuse New York, 13217, United States
Valhalla New York, 10595, United States
Yonkers New York, 10701, United States
Chapel Hill North Carolina, 27599, United States
Concord North Carolina, 28025, United States
Greenville North Carolina, 27858, United States
Hickory North Carolina, 28601, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58122, United States
Minot North Dakota, 58701, United States
Akron Ohio, 44302, United States
Akron Ohio, 44309, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45429, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73101, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74104, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18103, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Darby Pennsylvania, 19023, United States
Drexel Hill Pennsylvania, 19026, United States
East Stroudsburg Pennsylvania, 18301, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15219, United States
Pittsburgh Pennsylvania, 15224, United States
Reading Pennsylvania, 19612, United States
Scranton Pennsylvania, 18501, United States
Sellersville Pennsylvania, 18960, United States
Wilkes-Barre Pennsylvania, 18764, United States
Wynnewood Pennsylvania, 19096, United States
York Pennsylvania, 17315, United States
Providence Rhode Island, 02908, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57709, United States
Jackson Tennessee, 38301, United States
Memphis Tennessee, 38103, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Beaumont Texas, 77701, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
Lubbock Texas, 79410, United States
Pasadena Texas, 77504, United States
Tyler Texas, 75701, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84132, United States
Salt Lake City Utah, 84143, United States
Bennington Vermont, 05201, United States
Burlington Vermont, 05401, United States
Rutland Vermont, 05701, United States
Charlottesville Virginia, 22901, United States
Charlottesville Virginia, 22908, United States
Harrisonburg Virginia, 22801, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98111, United States
Spokane Washington, 99210, United States
Yakima Washington, 98902, United States
Wheeling West Virginia, 26003, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53713, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53210, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Racine Wisconsin, 53405, United States
Waukesha Wisconsin, 53188, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Saint John New Brunswick, E2L 4, Canada
St. Johns Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 1, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7A 7, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Fleurimont Quebec, J1H 5, Canada
Montreal Quebec, H2L-4, Canada
Montreal Quebec, H2W 1, Canada
Quebec City Quebec, G1R 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
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