- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002470
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 weeks. Treatment continues every 12 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 1, 7, and 11 of each course.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- George Washington University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Robert K. Oldham, MD, Cancer Therapeutics, Incorporated
Publications and helpful links
General Publications
- 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 Clinical Oncology 14: A-552, 219, 1995.
- 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 Society of Clinical Oncology 12: A-661, 218, 1993.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Gastrointestinal Neoplasms
- Carcinoid Tumor
- Malignant Carcinoid Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Fluorouracil
Other Study ID Numbers
- MAOP-5190
- CDR0000076667 (Registry Identifier: PDQ (Physician Data Query))
- NBSG-9010
- NCI-V90-0197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on recombinant interferon alfa
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBladder Cancer | Urethral CancerUnited States
-
Seoul National University HospitalHanyang UniversityRecruitingCoronary Artery Disease | Stable Angina | Acute Myocardial InfarctionKorea, Republic of
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | Metastatic CancerUnited States
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
Hoffmann-La RocheCompletedRenal Cell Carcinoma | Chronic Myelogenous Leukemia | Malignant MelanomaCanada, India, Bulgaria, Russian Federation, Spain, South Africa, Slovakia
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI); NCIC Clinical Trials Group; Children's Oncology... and other collaboratorsActive, not recruitingMelanoma (Skin)United States, Canada, Australia, South Africa
-
Institute of Cancer Research, United KingdomCompletedMelanoma (Skin)United Kingdom
-
Hackensack Meridian HealthNational Cancer Institute (NCI)WithdrawnMelanoma (Skin)United States