Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003925
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy In Treating Patients With Advanced Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study of Gemcitabine Gemzar and UFTLeucovorin
Status:
COMPLETED
Status Verified Date:
2013-04
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 combining gemcitabine fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of combining gemcitabine fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated doses of gemcitabine fluorouracil-uracil UFT and leucovorin calcium in patients with advanced refractory cancer
Assess the toxicity of this combination regimen in this patient population
Evaluate this regimen in terms of response rate response duration and overall survival in these patients
OUTLINE This is a dose escalation study of gemcitabine and fluorouracil-uracil
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil UFT three times a day on days 1-21 Courses are repeated every 28 days Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Determine the maximum tolerated doses of gemcitabine fluorouracil-uracil UFT and leucovorin calcium in patients with advanced refractory cancer
Assess the toxicity of this combination regimen in this patient population
Evaluate this regimen in terms of response rate response duration and overall survival in these patients
OUTLINE This is a dose escalation study of gemcitabine and fluorouracil-uracil
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil UFT three times a day on days 1-21 Courses are repeated every 28 days Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 36 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 |
|---|---|---|---|
| NCI-G99-1526 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-1641 | None | None | None |
| WSU-04-28-98-M02-FB | None | None | None |