5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Condition: Gastrointestinal Cancer Metastatic; Renal Cell Cancer Metastatic; Non Small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Renal Cell; Neoplasms; Gastrointestinal Neoplasms
Intervention: 5-Fluorouracil and Interferon
Intervention description: 5-Fluorouracil Interferon-alfa-2b
Intervention MeSH terms: Interferons; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Gastrointestinal; Metastatic Kidney; Metastatic Lung

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.
    

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.