Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053820
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2003-02-05
Brief Title:
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Controlled Trial of Interferon-alpha Interleukin-2 and 5-Fluorouracil vs Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2006-08
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 Interferon alfa may interfere with the growth of tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer
Detailed Description:
OBJECTIVES
Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil
Compare the toxicity of these regimens in these patients
Assess the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Interferon alfa monotherapy Patients receive interferon alfa subcutaneously SC on days 1 3 and 5 Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity
Arm II Interferon alfa interleukin-2 and fluorouracil combination therapy Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1 3 and 5 of weeks 2 3 5 6 7 and 8 Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1 3 and 5 of weeks 2 and 3 Patients then receive fluorouracil IV on day 1 of weeks 5-8 Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at 9 19 and 26 weeks and then at 8 months
Patients are followed at 8 10 and 12 months every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 670 patients 335 per treatment arm will be accrued for this study
Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil
Compare the toxicity of these regimens in these patients
Assess the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Interferon alfa monotherapy Patients receive interferon alfa subcutaneously SC on days 1 3 and 5 Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity
Arm II Interferon alfa interleukin-2 and fluorouracil combination therapy Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1 3 and 5 of weeks 2 3 5 6 7 and 8 Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1 3 and 5 of weeks 2 and 3 Patients then receive fluorouracil IV on day 1 of weeks 5-8 Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at 9 19 and 26 weeks and then at 8 months
Patients are followed at 8 10 and 12 months every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 670 patients 335 per treatment arm 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 |
|---|---|---|---|
| ISRCTN46518965 | None | None | None |
| MRC-RE04 | None | None | None |
| EORTC-30012 | None | None | None |
| EU-20231 | None | None | None |