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Sponsors and Collaborators: |
Mid-Atlantic Oncology Program Cancer Biotherapy Research Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002470 |
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.
Condition | Intervention | Phase |
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Gastrointestinal Carcinoid Tumor Lung Cancer |
Biological: recombinant interferon alfa Drug: fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid |
Study Start Date: | September 1990 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet at least 1 of the following conditions:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |
George Washington University Medical Center | |
Washington, District of Columbia, United States, 20037 |
Study Chair: | James D. Ahlgren, MD | George Washington University |
Study Chair: | Robert K. Oldham, MD | Cancer Therapeutics, Incorporated |
Study ID Numbers: | CDR0000076667, MAOP-5190, NBSG-9010, NCI-V90-0197 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002470 History of Changes |
Health Authority: | United States: Federal Government |
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor pulmonary carcinoid tumor |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Gastrointestinal Diseases Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Syndrome Interferon-alpha Digestive System Neoplasms Interferons Serotonin Syndrome |
Malignant Carcinoid Syndrome Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Recurrence Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Digestive System Diseases Lung Diseases Fluorouracil Gastrointestinal Neoplasms Carcinoid Tumor Adenocarcinoma Interferon Alfa-2a |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Neoplasms, Nerve Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Growth Inhibitors Angiogenesis Modulating Agents Interferon-alpha Respiratory Tract Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Growth Substances Interferons Malignant Carcinoid Syndrome Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Carcinoma |