Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer - Full Text View

Sponsor:	Mount Sinai School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002796

Purpose

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	Intervention	Phase
Colorectal Cancer	Biological: recombinant interferon gamma Drug: fluorouracil Drug: indomethacin Drug: sodium phenylbutyrate	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Indomethacin Interferon gamma-1b Sodium phenylbutyrate Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 1997

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002796

Locations

United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029

Sponsors and Collaborators

Mount Sinai School of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Max W. Sung, MD

Mount Sinai School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000064879, MTS-96322-ME, NCI-T96-0015O
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002796 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer

recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Interferon Type II
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Colonic Diseases
Reproductive Control Agents
Gout Suppressants
Rectal Diseases
Neoplasms by Site

Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Digestive System Neoplasms
4-phenylbutyric acid
Cyclooxygenase Inhibitors
Interferons
Enzyme Inhibitors
Cardiovascular Agents
Intestinal Diseases
Antiviral Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 27, 2009