BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of BBR 3464 as First Line Treatment in Patients With Inoperable, Locally Advanced or Metastatic Adenocarcinoma of the Pancreas|
|Study Start Date:||May 2001|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024362
|United States, Arizona|
|Arizona Oncology Associates|
|Tucson, Arizona, United States, 85712-2254|
|United States, California|
|Alta Bates Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Kentucky|
|Albert B. Chandler Medical Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536-0084|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Oklahoma|
|Oklahoma Oncology Inc.|
|Tulsa, Oklahoma, United States, 74104|
|United States, Tennessee|
|Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group|
|Memphis, Tennessee, United States, 38119|
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||George L. Miller, MD||Oklahoma Oncology, Incorporated at LaFortune Cancer Center|