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BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment Clinical research trials and BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment clinical trial. Test subjects typically receive the most expert healthcare available for their BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment  BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
For Condition: extensive stage small cell lung cancer,Recurrent Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have metastatic small cell lung cancer that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the efficacy of BBR 3464 in terms of response rate in patients with sensitive or refractory metastatic small cell lung cancer. II. Determine the duration of response and time to progression in patients treated with this drug. III. Determine the overall survival of patients treated with this drug. IV. Determine the incidence and severity of toxic effects of this drug in this patient population. V. Determine the pharmacokinetics of this drug in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to disease (refractory vs sensitive). Patients receive BBR 3464 IV over 1 hour on day 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may receive up to 6 courses of therapy. Patients without progressive disease after 6 courses may continue treatment at the investigator's discretion. Patients are followed every 9 weeks for 3 years. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) 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 metastatic small cell lung cancer (SCLC) - Must have sensitive or refractory disease after first-line chemotherapy; Refractory Progressive or stable disease during chemotherapy; Relapse after a response during treatment; Relapse after a response within 3 months after completing chemotherapy; Sensitive; Relapse after a response of at least 3 months duration after completing chemotherapy - At least 1 measurable lesion; No previously irradiated lesions - No symptomatic brain or leptomeningeal metastasis --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy for SCLC and recovered; No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for carboplatin at doses of at least 500 mg/m2 or AUC more than 7 mg/mL) and recovered; No more than 1 prior chemotherapy regimen; No concurrent chemotherapy - Endocrine therapy: At least 4 weeks since prior hormonal therapy for SCLC and recovered; No concurrent steroids for brain metastasis; No concurrent hormonal therapy - Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered; No concurrent radiotherapy except palliative local radiotherapy for non-target lesions - Surgery: At least 4 weeks since prior major surgery and recovered - Other: At least 30 days since prior investigational drugs and recovered; No other concurrent anti-cancer therapy; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: Hemoglobin at least 9 g/dL; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN; ALT or AST no greater than 2.5 times ULN; Albumin at least 2.5 g/dL - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min (60 mL/min if treated with prior cisplatin therapy) - Cardiovascular: No congestive heart failure or angina pectoris (even if medically controlled); No myocardial infarction within the past year; No uncontrolled hypertension or arrhythmia - Other: No other serious illness or medical condition; No history of significant neurologic disorder (other than metastatic disease or psychiatric disorder); No uncontrolled infection; No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, carcinoma in situ or the cervix, or other surgically cured cancer; No other condition that would preclude study; Not pregnant or nursing Negative pregnancy test; Fertile patients must use effective contraception during and for at least 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkSocinski, Study Chair, Theradex
Cancer Services
Columbus, Ohio, 43214
United States
Indiana Cancer Pavilion
Indianapolis, Indiana, 46202
United States
Office of Peter D. Byeff
Southington, Connecticut, 06489
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Theradex
Princeton, New Jersey, 08543
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
University Hospital Lexington
Lexington, Kentucky, 40536-0084
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Clinical Research Consultants, Inc
Hoover, Alabama, 35216
United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, 72703
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Additional Information:
Study ID Numbers: CDR0000068555; NCI-V01-1653,THERADEX-TPT-II-04,NOVUSPHARMA-TPT-II-04
Study Start Date: November 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014547
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
2. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
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BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
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