Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002470
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
1999-11-01
Brief Title:
Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
Sponsor:
Mid-Atlantic Oncology Program
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Protracted Infusional 5-Fluorouracil Plus Alpha Interferon for Advanced Metastatic Carcinoid
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Phase II trial to study the effectiveness of fluorouracil plus interferon alfa in treating patients who have advanced metastatic carcinoid tumors
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V90-0197 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000076667 | REGISTRY | None | None |
| NBSG-9010 | None | None | None |