Completed

A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid

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What is being tested

recombinant interferon alfa

+ fluorouracil

BiologicalDrug
Who is being recruted

Lung Diseases+4

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1990
See protocol details

Summary

Principal SponsorMid-Atlantic Oncology Program
Last updated: May 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1990

Actual date on which the first participant was enrolled.

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.

NCT00002470
Principal SponsorMid-Atlantic Oncology Program
Last updated: May 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

George Washington University Medical Center

Washington D.C., United StatesOpen George Washington University Medical Center in Google Maps
CompletedOne Study Center