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Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer. Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer  Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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 chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. - Determine the toxicity of this regimen in these patients. - Determine the overall and failure-free survival of patients treated with this regimen. - Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen. OUTLINE: This is a multicenter study. - Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. - Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer - Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes - Measurable disease - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Lesions not considered measurable include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - Tumor lesions in a previously irradiated area - No clinically suspected or confirmed supraclavicular lymph node metastases - No pleural effusions visible on plain chest radiographs, regardless of cytology 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 100,00/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 - Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other currently active malignancy except non-melanoma skin cancer - Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy: - No prior chemotherapy for small cell lung cancer - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except: - Steroids for adrenal failure - Hormones for non-disease-related conditions (e.g., insulin for diabetes) - Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: - See Disease Characteristics - No prior chest radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoniusMiller, Study Chair, Comprehensive Cancer Center of Wake Forest University
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000069313; CLB-30002
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033696
Other Limited Stage Small Cell Lung Cancer Studies:
1. Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy
2. Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
3. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
4. Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
5. Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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