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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer  Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
For Condition: Recurrent Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.
Details: OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan. II. Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population. PROTOCOL OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent or refractory small cell lung cancer - Measurable disease; At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan; The following are not considered measurable: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions; Tumor lesions situated in a previously irradiated area - Known CNS metastases allowed --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 1 prior chemotherapy or chemoradiotherapy regimen; No prior gemcitabine or irinotecan - Endocrine therapy: Not specified - Radiotherapy: No more than 1 prior chemoradiotherapy regimen; At least 2 weeks since prior cranial radiotherapy for CNS metastases; No concurrent cranial radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: CTC 0-2 - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 2.0 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CaioS. Rocha Lima, Study Chair, Cancer and Leukemia Group B
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
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 - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Additional Information:
Study ID Numbers: CDR0000067959; CLB-39902
Study Start Date: May 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005972
Other Recurrent Small Cell Lung Cancer Studies:
1. Interferon alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
2. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
3. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
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