Clinical trial · Interventional
Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
NCT00002470CI-TRIAL-00010321completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAhlgren JD, Leming PD, Gullo JJ, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN) in metastatic carcinoid: updated experience with Mid-Atlantic Oncology Program (MAOP) study 5190. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-552, 219, 1995.
- RESULTAhlgren JD, Leming PD, Fryer D, et al.: Protracted infusional 5-FU (PIF) + alpha2b-interferon (alpha-IFN): a well tolerated regimen for palliation of advanced carcinoid: a Mid-Atlantic Oncology Program (MAOP) study. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-661, 218, 1993.