Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
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.
Gastrointestinal Carcinoid Tumor
Biological: recombinant interferon alfa
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid|
|Study Start Date:||September 1990|
|Study Completion Date:||January 2004|
- 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.
|United States, District of Columbia|
|George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|Study Chair:||James D. Ahlgren, MD||George Washington University|
|Study Chair:||Robert K. Oldham, MD||Cancer Therapeutics, Incorporated|