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Related Studies
Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Mount Sinai School of Medicine
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antimetabolites
Interferon Type II
Immunologic Factors
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Rectal Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Digestive System Neoplasms
4-phenylbutyric acid
Interferons
Cyclooxygenase Inhibitors
 Rectal Neoplasm
Cardiovascular Agents
Intestinal Diseases
Antiviral Agents
Immunosuppressive Agents
Intestinal Neoplasms
Recurrence
Rectal Cancer
Digestive System Diseases
Analgesics, Non-Narcotic
Fluorouracil
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Adenocarcinoma
Antirheumatic Agents

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 July 02, 2009



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