Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002470
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2013
Cancer Biotherapy Research Group
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
May 15, 2013
September 1990
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Complete list of historical versions of study NCT00002470 on Archive Site
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Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Gastrointestinal Carcinoid Tumor
  • Lung Cancer
  • Biological: recombinant interferon alfa
  • Drug: fluorouracil
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  • 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2004
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  • 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



  • 18 and over

Performance status:

  • Zubrod 0-2


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


  • Bilirubin no greater than 3.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • See Disease Characteristics


  • See Disease Characteristics


  • 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


Biologic therapy:

  • No prior interferon therapy


  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior endocrine therapy allowed
  • Concurrent octreotide allowed


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


  • See Disease Characteristics
  • Prior surgery allowed


  • No prior fluorinated pyrimidine
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000076667 ( Registry Identifier: PDQ (Physician Data Query) )
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Mid-Atlantic Oncology Program
Cancer Biotherapy Research Group
Study Chair: James D. Ahlgren, MD George Washington University
Study Chair: Robert K. Oldham, MD Cancer Therapeutics, Incorporated
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP