BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00024362
- 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 locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
- Detailed Description
OBJECTIVES: I. Determine the overall survival of patients with inoperable locally advanced or metastatic adenocarcinoma of the pancreas treated with BBR 3464. II. Determine the response rate, duration of response, time to disease progression, and duration of stable disease in patients treated with this drug. III. Determine the incidence and severity of the toxic effects of this drug in these patients. IV. Determine the disease-related symptoms in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive BBR 3464 IV over 1 hour on day 1. Treatment repeats every 21 days for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks.
PROJECTED ACCRUAL: A total of 50 patients 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 (9)
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Oklahoma Oncology Inc.
🇺🇸Tulsa, Oklahoma, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
🇺🇸Memphis, Tennessee, United States