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 |
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.
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.
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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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Missouri Baptist Cancer Center The Cancer Center at Missouri Baptist is a member of Heartland...
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3700 O Street Northwest
Washington, District of Columbia 20007
Washington, District of Columbia 20007
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6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
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Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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Winston-Salem, North Carolina 27157
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