Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate, Indomethacin and Recombinant Human Interferon-Gamma in Advanced Colorectal Cancer

Study start date: May 1, 1997

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