Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009828
Status:
WITHDRAWN
Last Update Posted:
2013-12-19
First Post:
2001-02-02
Brief Title:
Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study Of Weekly Paclitaxel In Combination With ORZEL UFT Leucovorin For Advanced Non-Hematological Malignancies
Status:
WITHDRAWN
Status Verified Date:
2013-12
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of weekly paclitaxel when combined with fluorouracil-uracil and leucovorin calcium in patients with solid tumors II Determine the side effects and toxicity of this regimen in these patients
OUTLINE This is a dose escalation study of paclitaxel Patients receive paclitaxel IV on days 1 8 and 15 Patients also receive oral fluorouracil-uracil and leucovorin calcium twice daily on days 2-6 9-13 and 16-20 Treatment repeats every 4 weeks for up to 6 courses in the absence of progressive disease or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed at 2 months and then for survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
OUTLINE This is a dose escalation study of paclitaxel Patients receive paclitaxel IV on days 1 8 and 15 Patients also receive oral fluorouracil-uracil and leucovorin calcium twice daily on days 2-6 9-13 and 16-20 Treatment repeats every 4 weeks for up to 6 courses in the absence of progressive disease or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed at 2 months and then for survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068413 | REGISTRY | None | None |
| PCI-IRB-990929 | None | None | None |
| NCI-G00-1903 | Registry Identifier | PDQ Physician Data Query | None |