Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/21/2016
Start Date:March 1999
End Date:March 2006

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Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

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 drug and giving them before and with radiation therapy may be
an effective treatment for limited-stage small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in
treating patients who have limited-stage small cell lung cancer.

OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan
followed by consolidation chemoradiotherapy in patients with limited stage small cell lung
cancer. II. Determine the toxic effects of this regimen in this patient population. III.
Describe the pattern of relapse, documenting carefully the location of relapse with respect
to the original disease volume and the radiation treatment field in these patients. IV.
Determine the overall and failure free survival of these patients.

OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1.
Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood
counts recover. The course is repeated once beginning on day 22. After restaging, patients
begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that
radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV
over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every
21 days for a total of 3 courses. Patients with stable or responding disease undergo
prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years,
every 6 months for 3 years, and then at least every year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18
months.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited stage small
cell lung cancer Includes disease restricted to one hemithorax with regional lymph node
metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes
Clinically suspected or confirmed supraclavicular lymph node metastases and pleural
effusions that are visible on plain chest radiographs, whether cytologically positive or
not, are not eligible Unidimensionally or bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of
normal (ULN) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile
patients must use effective contraception No concurrent active second malignancy except
nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30%
risk of relapse)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine
therapy: No concurrent steroids except for adrenal failure No concurrent hormones except
for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone
except for intermittent use as an antiemetic or as an adjunct to prophylactic cranial
irradiation Radiotherapy: No prior mediastinal radiotherapy Surgery: Not specified
We found this trial at
48
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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300 Community Drive
Manhasset, New York 11030
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1331 Union Ave # 800
Memphis, Tennessee 38103
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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700 19th Street South
Birmingham, Alabama 35233
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Burlington, Vermont 05405
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Columbia, Missouri 65203
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Durham, North Carolina 27705
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Lebanon, New Hampshire 03756
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Minneapolis, Minnesota 55417
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New York, New York 10029
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Richmond, Virginia 23298
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Saint Louis, Missouri 63110
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3015 N Ballas Rd
Saint Louis, Missouri 63131
(314) 996-5151
Missouri Baptist Cancer Center The Cancer Center at Missouri Baptist is a member of Heartland...
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San Francisco, California 94143
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San Francisco, California 94121
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3700 O Street Northwest
Washington, District of Columbia 20007
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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White River Junction, Vermont 05009
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Wilmington, Delaware 19899
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Winston-Salem, North Carolina 27104
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