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| Sponsors and Collaborators: |
Mid-Atlantic Oncology Program 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 |
Drug: fluorouracil Drug: recombinant interferon alfa |
Phase II |
| MedlinePlus related topics: | Cancer Carcinoid Tumors Lung Cancer |
| ChemIDplus related topics: | Fluorouracil Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
| 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.
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 | |||||
| Mid-Atlantic Oncology Program |
| Cancer Biotherapy Research Group |
| Study Chair: | James D. Ahlgren, MD | George Washington University |
| Study Chair: | Robert K. Oldham, MD | Cancer Therapeutics, Incorporated |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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.
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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 ID Numbers: | CDR0000076667, MAOP-5190, NBSG-9010, NCI-V90-0197 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002470 |
| Health Authority: | United States: Federal Government |
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