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

Inclusion 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