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

Stopped early · Phase 1/Phase 2

Conditions studied: Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

In brief

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of giving fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how well it works in treating patients with stage IV colorectal cancer

Key facts

Study ID

NCT00002796

Run by

National Cancer Institute (NCI)

People needed

46

Starts

1997-05-01

Last updated by the study team

2013-02-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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