Pancreatic Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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