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| Descriptive Information Fields | |||||||||
| Brief Title † | Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors | ||||||||
| Official Title † | A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Gastrointestinal Carcinoid Tumor Lung Cancer |
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| Intervention † | Drug: fluorouracil Drug: recombinant interferon alfa |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | |||||||||
| Start Date † | September 1990 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00002470 | ||||||||
| Organization ID | CDR0000076667 | ||||||||
| Secondary IDs †† | MAOP-5190, NBSG-9010, NCI-V90-0197 | ||||||||
| Study Sponsor † | Mid-Atlantic Oncology Program | ||||||||
| Collaborators †† | Cancer Biotherapy Research Group | ||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | December 2003 | ||||||||
| First Received Date † | November 1, 1999 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||