A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
recombinant interferon alfa
+ fluorouracil
Lung Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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