Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer

Inclusion Criteria

• •Stage IV colorectal adenocarcinoma, excluding brain metastases
• •Histological confirmation of colorectal adenocarcinoma
• •Previously untreated patients
• •Previously treated patients
• •* For the Phase I trial, no limitations
• •* For the Phase II trial, previous treated limited to adjuvant radiation and/or chemotherapy which is completed at least 12 months before documentation of metastatic disease; patients may not have received chemotherapy for metastatic disease
• •For the Phase I trial, patients may have measurable disease or unmeasurable disease; for the Phase II trial, patients must have measurable disease in at least two dimensions on x-rays, CT scan or MRI
• •Expected survival of at least 16 weeks
• •Performance status of \>= 70% (Karnofsky)
• •WBC \>= 3000 uL
• •Platelet count \>= 100,000/uL
• •Bilirubin =\< 2 x ULN
• •Creatinine =\< 2 x ULN
• •Not pregnant and not lactating; women of child bearing age must have negative pregnancy test (beta-hcg)
• •No allergies to interferon-gamma or E.coli derived products
• •No serious medical intercurrent medical illnesses, including Class III or IV cardiovascular disease; patient may not be dependent on immunosuppressive drugs including corticosteroids, and may not receive these drugs for the entire duration of the study
• •No diarrhea, and with adequate oral intake
• •Patients of child-bearing age and potential must agree to use adequate birth control other than oral contraceptives for the entire duration of the study
• •No previous or concurrent malignancy except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, grade 1 bladder cancer, or other cancers if the patient has been disease free for \>= 5 years
• •Patients must be oriented and rational, and aware of the investigational nature of the study