BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
NCT ID: NCT00014547
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2000-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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BBR 3464
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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Mark A. Socinski, MD
Role: STUDY_CHAIR
UNC Lineberger Comprehensive Cancer Center
Locations
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Clinical Research Consultants, Inc
Hoover, Alabama, United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Office of Peter D. Byeff
Southington, Connecticut, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Indiana Cancer Pavilion
Indianapolis, Indiana, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States
University Hospital Lexington
Lexington, Kentucky, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University Barnard Cancer Center
St Louis, Missouri, United States
Theradex
Princeton, New Jersey, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Cancer Services
Columbus, Ohio, United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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THERADEX-TPT-II-04
Identifier Type: -
Identifier Source: secondary_id
NOVUSPHARMA-TPT-II-04
Identifier Type: -
Identifier Source: secondary_id
NCI-V01-1653
Identifier Type: -
Identifier Source: secondary_id
CDR0000068555
Identifier Type: -
Identifier Source: org_study_id