Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	MTS-96322-ME NCI-T96-0015O, NCT00002796, T96-0015

Objectives

1. Determine the maximum tolerated dose of fluorouracil administered with phenylbutyrate, indomethacin, and interferon gamma in patients with advanced colorectal adenocarcinoma.
2. Determine the toxic effects of this regimen in these patients.
3. Determine the efficacy of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 16 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

Mount Sinai Medical Center

Max Sung, MD, Protocol chair		Ph: 212-241-7902 Email: max.sung@mssm.edu

Registry Information
Official Title		Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer
Trial Start Date		1997-05-19
Registered in ClinicalTrials.gov		NCT00002796
Date Submitted to PDQ		1997-05-19
Information Last Verified		2003-10-23

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