Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045747
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-09-06
Brief Title:
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2004-08
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 UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining UCN-01 with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine
PURPOSE Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine
Detailed Description:
OBJECTIVES
Determine the response rate time to progression and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive fluorouracil IV over 24 hours on days 1 8 15 and 22 Patients also receive UCN-01 IV continuously over 72 hours course 1 only beginning on day 2 In subsequent courses UCN-01 is infused over 36 hours Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 3-13 months
Determine the response rate time to progression and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive fluorouracil IV over 24 hours on days 1 8 15 and 22 Patients also receive UCN-01 IV continuously over 72 hours course 1 only beginning on day 2 In subsequent courses UCN-01 is infused over 36 hours Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 3-13 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-5509 | None | None | None |
| MSKCC-02049 | None | None | None |