Gastric Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Either 5-Fluorouracil, Recombinant Alfa-2a-Interferon and Intravenous Hydroxyurea With Filgrastim Support (FHIG) or Doxorubicin/Docetaxel (Dd) in Patients With Advanced Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving drugs in different combinations and combining them with
interferon alfa and G-CSF may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination
chemotherapy regimens in treating patients with advanced stomach cancer.
OBJECTIVES: I. Evaluate the objective response rates for two different regimens in patients
with advanced gastric cancer: the combination of fluorouracil plus hydroxyurea given as high
dose 24 hour infusions plus interferon alfa-2a and filgrastim; versus the combination of
doxorubicin and docetaxel. II. Evaluate the toxicities and reversibility of toxicities of
each of these combinations in patients with advanced gastric cancer.
OUTLINE: This is an open label, two arm, multicenter, randomized study. Arm I: Patients
receive fluorouracil (5-FU), recombinant alfa-2a interferon, hydroxyurea (HU), and
filgrastim (granulocyte colony-stimulating factor; G-CSF). 5-FU is administered by 24 hour
infusion on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Recombinant alfa-2a interferon is
administered subcutaneously immediately before beginning the 5-FU infusion, then three times
a week for 6 weeks. HU is administered by 24 hour infusion on days 1, 8, 15, 22, 29, and 36
(weeks 1-6). G-CSF is administered subcutaneously on days 3, 4, 5, and 6 on weeks 1-6. Weeks
7 and 8 are rest periods. Arm II: Patients receive doxorubicin administered by slow IV push
followed (30 minutes after infusion) by docetaxel as a 1 hour IV infusion. Treatment is
repeated every 21 days. All patients are assessed monthly during study and continue study
treatment as long as no disease progression or unacceptable toxic effects are observed.
Patients are followed every 3 months for the first 2 years, then every 6 months for years
2-5, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 26 patients (13 in each arm) and a maximum of 80 patients
(40 in each arm) will be accrued in this study in approximately 2 years.
;
Primary Purpose: Treatment
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