Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006486
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-11-06
Brief Title:
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole CAI NSC 609974 In Metastatic Renal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma
II Determine the objective response rate in patients treated with this drug
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to time from diagnosis of metastatic disease to study entry fewer than 24 months vs 24 months or more
Patients receive oral carboxyamidotriazole CAI daily for 4 weeks Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity
Patients with stable disease are randomized to one of two treatment arms
Arm I Patients receive oral CAI as above
Arm II Patients receive a placebo
Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 335 patients will be accrued for this study within 15-25 months
I Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma
II Determine the objective response rate in patients treated with this drug
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to time from diagnosis of metastatic disease to study entry fewer than 24 months vs 24 months or more
Patients receive oral carboxyamidotriazole CAI daily for 4 weeks Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity
Patients with stable disease are randomized to one of two treatment arms
Arm I Patients receive oral CAI as above
Arm II Patients receive a placebo
Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 335 patients will be accrued for this study within 15-25 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068317 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-69901 | None | None | None |
| U10CA031946 | NIH | None | None |