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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mid-Atlantic Oncology Program
• Collaborator: Cancer Biotherapy Research Group
• Treatments: Fluorouracil; Interferon-alpha; Interferons

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