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

This study has been completed.
Sponsor:
Collaborator:
Cancer Biotherapy Research Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002470
First received: November 1, 1999
Last updated: May 14, 2013
Last verified: December 2003
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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
Study Completion Date: January 2004
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

ClinicalTrials.gov Identifier: NCT00002470     History of Changes
Other Study ID Numbers: MAOP-5190, CDR0000076667, NBSG-9010, NCI-V90-0197
Study First Received: November 1, 1999
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Interferons
Fluorouracil
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 19, 2014