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| Sponsor: | Mid-Atlantic Oncology Program |
|---|---|
| Collaborator: |
Cancer Biotherapy Research Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002470 |
Purpose
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 |
|---|---|---|
|
Gastrointestinal Carcinoid Tumor Lung Cancer |
Biological: recombinant interferon alfa Drug: fluorouracil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00002470 History of Changes |
| Other Study ID Numbers: | CDR0000076667, MAOP-5190, NBSG-9010, NCI-V90-0197 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor pulmonary carcinoid tumor |
|
Carcinoid Tumor Lung Neoplasms Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Interferon-alpha Interferon Alfa-2a Interferons Fluorouracil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors |