A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
recombinant interferon alfa
+ fluorouracil
Maladies pulmonaires+4
+ Néoplasmes
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1990
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
George Washington University Medical Center
Washington D.C., United StatesOuvrir George Washington University Medical Center dans Google Maps