Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: fluorouracil (Drug); indomethacin (Drug); recombinant interferon gamma (Drug); sodium phenylbutyrate (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Mount Sinai School of Medicine Official(s) and/or principal investigator(s):
Max W. Sung, MD, Study Chair, Affiliation: Mount Sinai School of Medicine
Summary
RATIONALE: 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.
PURPOSE: 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.
Clinical Details
Official title: Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer
Study design: Treatment
Detailed description:
OBJECTIVES:
- Determine the maximum tolerated dose of fluorouracil administered with phenylbutyrate,
indomethacin, and interferon gamma in patients with advanced colorectal adenocarcinoma.
- Determine the toxic effects of this regimen in these patients.
- Determine the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of fluorouracil (5-FU).
- Phase I: Patients receive 5-FU IV over 24 hours on day 1; phenylbutyrate IV over 120
hours and oral indomethacin daily on days 2-6; and interferon gamma subcutaneously on
days 2, 4, and 6. Courses repeat weekly in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which less than 2 of 6 patients
experience dose-limiting toxicity (DLT).
- Phase II :Patients receive 5-FU, phenylbutyrate, indomethacin, and interferon gamma as
in phase I at the MTD.
Patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for the phase I portion of this
study and approximately 46 patients will be accrued for the phase II portion of this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV colorectal adenocarcinoma
- Bidimensionally measurable disease on x-ray, CT scan, or MRI required for phase II
patients
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 16 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- No New York Heart Association class III-IV heart disease
Nutritional:
- Adequate oral intake
- No diarrhea
Other:
- No other serious concurrent illness
- No dependence on immunosuppressive drugs, including corticosteroids
- No other malignancy within the past 5 years except:
- Inactive nonmelanoma skin cancer
- Carcinoma in situ of the cervix
- Grade I bladder cancer
- No allergy to interferon gamma or E. coli-derived products
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for metastatic disease
- At least 12 months since prior adjuvant chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 12 months since prior adjuvant radiotherapy
Surgery
- Not specified
Other
- No concurrent immunosuppressive drugs
Locations and Contacts
Mount Sinai Medical Center, New York, New York 10029, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1997
Last updated: May 23, 2008
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