5-fluorouracil followed by interferon-alfa-2b in previously-treated metastatic gastrointestinal, kidney, or lung cancer

Conditions: Gastrointestinal Cancer Metastatic; Renal Cell Cancer Metastatic; Non Small Cell Lung Cancer Metastatic

Summary: the purpose of this study is to determine whether the combination of a 5-fluorouracil (5-fu) and interferon, which is able to stimulate the immune system to kill cancer cells, will help to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or lung cancer.

interferon with continuous infusion 5-fluorouracil (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.

Eligibility criteria:
inclusion criteria: * patients must have histologically-proven, metastatic gastrointestinal, kidney, or lung cancer who have had disease progression on at least two prior systemic therapies. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 and estimated survival of at least 3 months. * patients must be felt to have recovered from effects of prior therapy, such as past expected white blood count nadir for chemotherapy (\> 2 weeks for most agents, \> 6 weeks for nitrosoureas or mitomycin-c) * patient consent must be obtained prior to entrance onto study. * white blood count \> 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin \> 9.0 gm/dl; bilirubin, aspartate aminotransferase (ast), alanine aminotransferase (alt) less than 3 times the upper limit of normal; serum creatinine \< 1.8. * corticosteroids and immunosuppressive agents are not permitted during the course of the study. patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study. * patients with elevated temperatures \> 100.5 degrees f, must have sources of occult infection excluded. * women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment. exclusion criteria: * evidence of significant cardiovascular disease including history of recent (\< 6 months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional pvc's, angina, or cerebrovascular accident. * prior history of psychiatric disorder that could be exacerbated by interferon therapy or which could preclude completion of this therapy. * pregnancy or lactation. * history of hypersensitivity to interferon alfa or fluoropyrimidines. * history of severe debilitating pulmonary disease, such as chronic obstructive pulmonary disease requiring continuous oxygen therapy. * history of autoimmune disease requiring immunosuppression. * documented inflammatory joint or systemic inflammatory disease (such as lupus) which could be exacerbated by interferon therapy.

Keywords: metastatic gastrointestinal metastatic kidney metastatic lung