Pancreatic Cancer Clinical Trial
Official title:
Phase II Trial of 2-Fluorouracil Recombinant Alpha-2a-Interferon and Intravenous Hydroxyurea With Filgrastim in Patients With Refractory GI Malignancies Grant Application Title: Parenteral Hydroxyurea: A Modulator in Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.
Colony-stimulating factors such as filgrastim may increase the number of immune cells found
in bone marrow or peripheral blood and may help a person recover from the side effects of
chemotherapy. Combining chemotherapy with interferon alfa may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and interferon
alfa followed by filgrastim in treating patients who have gastrointestinal tract cancer.
OBJECTIVES: I. Determine the objective response rates in patients with unresectable locally
advanced or advanced gastrointestinal malignancy treated with intravenous hydroxyurea,
fluorouracil, interferon alfa, and filgrastim (G-CSF). II. Determine the toxic effects of
this regimen in these patients. III. Determine the reversal of toxic effects of this regimen
in these patients.
OUTLINE: Patients are stratified according to site of primary disease (hepatobiliary vs
gastric vs pancreatic). Patients receive fluorouracil IV over 48 hours and hydroxyurea IV
over 48 hours on days 1, 8, 22, and 29. Patients also receive interferon alfa subcutaneously
(SC) on days 1, 3, and 5 and filgrastim (G-CSF) SC on days 3-6 of weeks 1, 2, 4, and 5.
Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity.
PROJECTED ACCRUAL: A total of 31-60 patients (18-33 with hepatobiliary or gastric cancer and
13-27 with pancreatic cancer) will be accrued for this study.
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