Lung Cancer Clinical Trial
Official title:
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
Verified date | December 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | George Washington University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Mid-Atlantic Oncology Program | Cancer Biotherapy Research Group |
United States,
Ahlgren 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
Ahlgren 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
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