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Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Mid-Atlantic Oncology Program
Cancer Biotherapy Research Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002470
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Combining interferon alfa with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus interferon alfa in treating patients who have advanced metastatic carcinoid tumors.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Lung Cancer
Biological: recombinant interferon alfa
Drug: fluorouracil
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid

Resource links provided by NLM:


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

Study Start Date: September 1990
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate and duration of remission in patients with advanced metastatic carcinoid tumors treated with fluorouracil and interferon alfa-2b.
  • Determine the symptomatic response in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.
  • Determine the survival characteristics of patients treated with this regimen.

OUTLINE: Patients receive fluorouracil IV continuously for 10 weeks and interferon alfa subcutaneously 3 times a week for 12 weeks. Treatment continues every 12 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 1, 7, and 11 of each course.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven carcinoid tumor with radiologically confirmed metastatic disease
  • Recurrence after surgery or radiotherapy allowed
  • Must meet at least 1 of the following conditions:

    • Symptomatic carcinoid syndrome not controlled
    • Other systemic symptoms (e.g., weight loss, anorexia)
    • 24 hour urinary 5-hydroxyindole acetic acid (5-HIAA) 100 mg or greater
    • Bone metastases
    • Carcinoid heart disease
    • Carcinoid asthma
  • Measurable disease or 24-hour urinary 5-HIAA 50 mg or greater required
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 3.0 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • See Disease Characteristics

Pulmonary:

  • See Disease Characteristics

Other:

  • No concurrent infection (no fever for at least 3 days prior to treatment unless fever due to tumor)
  • No significant medical or psychiatric illness that would preclude study or informed consent
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or curatively treated stage I carcinoma of the cervix
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interferon therapy

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior endocrine therapy allowed
  • Concurrent octreotide allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Prior surgery allowed

Other:

  • No prior fluorinated pyrimidine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002470

Locations
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Mid-Atlantic Oncology Program
Cancer Biotherapy Research Group
Investigators
Study Chair: James D. Ahlgren, MD George Washington University
Study Chair: Robert K. Oldham, MD Cancer Therapeutics, Incorporated
  More Information

Additional Information:
Publications:
Ahlgren JD, Leming PD, Gullo JJ, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN) in metastatic carcinoid: updated experience with Mid-Atlantic Oncology Program (MAOP) study 5190. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-552, 219, 1995.
Ahlgren JD, Leming PD, Fryer D, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN): a well tolerated regimen for palliation of advanced carcinoid: a Mid-Atlantic Oncology Program (MAOP) study. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-661, 218, 1993.

Study ID Numbers: CDR0000076667, MAOP-5190, NBSG-9010, NCI-V90-0197
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002470     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
pulmonary carcinoid tumor

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Gastrointestinal Diseases
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carcinoid Syndrome
Interferon-alpha
Digestive System Neoplasms
Interferons
Serotonin Syndrome
Malignant Carcinoid Syndrome
Immunosuppressive Agents
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Digestive System Diseases
Lung Diseases
Fluorouracil
Gastrointestinal Neoplasms
Carcinoid Tumor
Adenocarcinoma
Interferon Alfa-2a

Additional relevant MeSH terms:
Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Interferon Type I, Recombinant
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon-alpha
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Growth Substances
Interferons
Malignant Carcinoid Syndrome
Immunosuppressive Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma

ClinicalTrials.gov processed this record on September 01, 2009