Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Interferon with continuous infusion 5-FU regimens have shown response rates ranging from
0-43% in various cancers. Monthly bolus 5-FU + interferon-alfa-2b has not undergone formal
phase II testing. In a small pilot study, a 5 consecutive day schedule of 5-FU and
interferon-alfa-2b resulted in the limiting toxicities of diarrhea and mucositis. A more
limited schedule was recommended. Therefore, it is reasonable to examine such a schedule.
In the current study, 5-FU will be followed by interferon-alfa-2b daily for 3 days to
attempt to benefit from both the biochemical and immunologic mechanisms described above.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the progression free survival of patients with metastatic gastrointestinal, kidney, or lung cancer treated with of interferon-alfa-2b and 5-FU who have had disease progression on at least two prior systemic therapies.
Walter Quan, MD
Western Regional Medical Center, Inc.
United States: Food and Drug Administration
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