|
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer Clinical research trials and Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer  Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer,Recurrent Small Cell Lung Cancer,extensive stage small cell lung cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
Details: OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients. PROTOCOL OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC); Disease recurring at least 90 days following completion of first line chemotherapy; Partial or complete response to first line therapy - Must have at least one bidimensionally measurable non CNS lesion; May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing - Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 months since prior immunotherapy; No concurrent immunotherapy for SCLC - Chemotherapy: See Disease Characteristics; No prior topotecan; Only one prior chemotherapy regimen allowed; No other concurrent chemotherapy for SCLC - Endocrine therapy: See Disease Characteristics - Radiotherapy: See Disease Characteristics; At least 24 hours since prior radiotherapy; No concurrent radiotherapy for SCLC - Surgery: At least 4 weeks since prior surgery - Other: At least 30 days or five half lives since other prior investigational drugs; No prior drugs (e.g., cisapride) that would alter absorption or GI motility; No other concurrent investigational therapy for SCLC --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 2 months - Hematopoietic: WBC at least 3,500/mm3; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL (after transfusion, if needed) - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present); Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Other: No active uncontrolled infection; No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer; No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy; No uncontrolled emesis; No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility; No history of allergic reactions to compounds chemically related to topotecan; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NathanLevitan, Study Chair, Ireland Cancer Center
Brown University Oncology Group
Providence, Rhode Island, 02912
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Cooper Cancer Institute
Camden, New Jersey, 08103
United States
Cooper Hospital/University Medical Center
Voorhees, New Jersey, 08043
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
United States
Southwest Cancer Care
Poway, California, 92064
United States
Sidney Kimmel Cancer Center
San Diego, California, 92121
United States
Central Pennsylvania Hematology & Medical Oncology Associates, PC
Lemoyne, Pennsylvania, 17043-1440
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Rochester General Hospital
Rochester, New York, 14621
United States
Oncology and Hematology Associates, Inc.
Indianapolis, Indiana, 46219
United States
Baptist Hospital- Pensacola
Pensacola, Florida, 32522
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
St. Joseph Mercy Hospital
Pontiac, Michigan, 48341-2985
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, 23226
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Oncology Clinic, P.C.
Colorado Springs, Colorado, 80909
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Salem Research
Winston Salem, North Carolina, 27103
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
Office of Michael E. Lee
Norfolk, Virginia, 23502
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Santa Fe Hematology/Oncology
Santa Fe, New Mexico, 87505
United States
Alton Ochsner Medical Foundation Hospital
New Orleans, Louisiana, 70121
United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, 30912-3620
United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410
United States
Shands Cancer Center
Gainesville, Florida, 32610
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Texas Cancer Care
Ft. Worth, Texas, 76104
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Scripps Clinic
La Jolla, California, 92037
United States
Additional Information:
Study ID Numbers: CDR0000067097; CWRU-SKF-1598,NCI-G99-1524,SB-104864-A/396
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003917
Other Quality Of Life Studies:
1. Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
3. Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
4. Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
Related Studies:
Other Quality of Life Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
|
|
|
|
|
|
|
|
