Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030888
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2002-02-14
Brief Title:
UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
Sponsor:
University of California San Francisco
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase II trial to study the effectiveness of UCN-01 in treating patients who have unresectable stage III or stage IV kidney cancer
PURPOSE Phase II trial to study the effectiveness of UCN-01 in treating patients who have unresectable stage III or stage IV kidney cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of UCN-01 in terms of time to objective progression in patients with stage IV or unresectable stage III renal cell carcinoma
Determine the objective response rate in patients treated with this drug
OUTLINE Patients receive UCN-01 IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-61 patients will be accrued for this study within 15 months
Determine the efficacy of UCN-01 in terms of time to objective progression in patients with stage IV or unresectable stage III renal cell carcinoma
Determine the objective response rate in patients treated with this drug
OUTLINE Patients receive UCN-01 IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-61 patients will be accrued for this study within 15 months
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-5522 | None | None | None |
| UCSF-NCI-5522 | None | None | None |