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

Launched by MID-ATLANTIC ONCOLOGY PROGRAM · Jan 26, 2003

Keywords

ClinConnect Summary

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 w...

Gender

ALL

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