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

This study has been completed.
Study NCT00002470.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
Official Title  A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
Brief Summary

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.

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Gastrointestinal Carcinoid Tumor
Lung Cancer
Intervention  Drug: fluorouracil
Drug: recombinant interferon alfa
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  September 1990
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002470
Organization ID CDR0000076667
Secondary IDs †† MAOP-5190, NBSG-9010, NCI-V90-0197
Study Sponsor  Mid-Atlantic Oncology Program
Collaborators †† Cancer Biotherapy Research Group
Investigators 
Study Chair:     James D. Ahlgren, MD     George Washington University    
Study Chair:     Robert K. Oldham, MD     Cancer Therapeutics, Incorporated    
Information Provided By National Cancer Institute (NCI)
Verification Date December 2003
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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