Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005966
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2000-07-05
Brief Title:
Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-09
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-2b may interfere with the growth of the cancer cells Thalidomide may stop the growth of cancer by stopping blood flow to the tumor It is not yet known if interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without thalidomide in treating patients who have previously untreated metastatic or unresectable kidney cancer
Detailed Description:
OBJECTIVES
Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide
Compare the safety of these 2 regimens in these patients
Compare the quality of life of patients treated with these 2 regimens
Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior nephrectomy yes vs no disease-free interval no more than 1 year vs more than 1 year and ECOG performance status 0 vs 1 or 2 Patients are randomized to one of two treatment arms
Arm I Patients receive interferon alfa-2b subcutaneously SC twice daily beginning on day 1
Arm II Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR continue treatment for 24 weeks past CR
Quality of life is assessed prior to randomization and then every 4 weeks through week 24
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 346 patients 173 per arm will be accrued for this study within 2 years
Compare the overall and progression-free survival at 24 weeks in patients with previously untreated metastatic or unresectable renal cell carcinoma treated with interferon alfa-2b with or without thalidomide
Compare the safety of these 2 regimens in these patients
Compare the quality of life of patients treated with these 2 regimens
Compare the pharmacodynamic effects of these regimens on pharmacodynamic measurements of angiogenesis such as serum and plasma angiogenic factor levels in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior nephrectomy yes vs no disease-free interval no more than 1 year vs more than 1 year and ECOG performance status 0 vs 1 or 2 Patients are randomized to one of two treatment arms
Arm I Patients receive interferon alfa-2b subcutaneously SC twice daily beginning on day 1
Arm II Patients receive interferon alfa-2b as in arm I and oral thalidomide once daily beginning on day 1
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR continue treatment for 24 weeks past CR
Quality of life is assessed prior to randomization and then every 4 weeks through week 24
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 346 patients 173 per arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| ECOG-2898 | None | None | None |