Clinical Trial: Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Mount Sinai Medical Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


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: indomethacin
 Drug: interferon gamma
 Drug: phenylbutyrate
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: cytokine therapy
 Procedure: drug modulation
 Procedure: interferon therapy
Phase I
Phase II

MedlinePlus related topics:  Colorectal Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Patients With Advanced Colorectal Adenocarcinoma

Further Study Details: 


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




  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • 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


  • Not specified


Endocrine therapy

  • No concurrent corticosteroids


  • At least 12 months since prior adjuvant radiotherapy


  • Not specified


Location and Contact Information

New York
      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Max W. Sung, MD  212-241-7902 

Study chairs or principal investigators

Max W. Sung, MD,  Study Chair,  Mount Sinai Medical Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064879; MTS-96322-ME; NCI-T96-0015O; NCT00002796
Record last reviewed:  December 2002
Last Updated:  February 24, 2005
Record first received:  November 1, 1999 Identifier:  NCT00002796
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005