BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
- Conditions
- Lung Cancer
- Registration Number
- NCT00014547
- Lead Sponsor
- Theradex
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Highlands Oncology Group, P.A.
🇺🇸Fayetteville, Arkansas, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Indiana Cancer Pavilion
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Consultants, Inc
🇺🇸Hoover, Alabama, United States
Office of Peter D. Byeff
🇺🇸Southington, Connecticut, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
University Hospital Lexington
🇺🇸Lexington, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Theradex
🇺🇸Princeton, New Jersey, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Cancer Services
🇺🇸Columbus, Ohio, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States
Oklahoma Oncology Inc.
🇺🇸Tulsa, Oklahoma, United States