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
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.
Interventional
Primary Purpose: Treatment
Scott Wadler, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
CDR0000065978
NCT00003172
December 1997
September 2004
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Allegheny University Hospitals- Hahnemann | Philadelphia, Pennsylvania 19102-1192 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |