Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer - Article Indocin Suppositories
Clinical Trial: Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|stage IV colon cancer |
Stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
| Drug: fluorouracil |
Drug: interferon gamma
Procedure: biological response modifier therapy
Procedure: cytokine therapy
Procedure: drug modulation
Procedure: interferon therapy
|Phase I |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment
- 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).
- 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- Karnofsky 70-100%
- At least 16 weeks
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Creatinine no greater than 2 times ULN
- No New York Heart Association class III-IV heart disease
- Adequate oral intake
- No diarrhea
- 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
- No concurrent corticosteroids
- At least 12 months since prior adjuvant radiotherapy
- Not specified
- No concurrent immunosuppressive drugs
Location and Contact Information
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Max W. Sung, MD, Study Chair, Mount Sinai Medical Center
Record last reviewed: December 2002
Last Updated: February 24, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002796
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005