Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020644
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-07-11
Brief Title:
Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
Sponsor:
Advocate Lutheran General Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Continuous Infusion Gemcitabine
Status:
UNKNOWN
Status Verified Date:
2004-04
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 I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer
PURPOSE Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies
Determine the toxicity profile of this drug in these patients
OUTLINE This is a dose-escalation study
Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1 Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3 Courses repeat every 2 weeks for patients on dose levels 1-5 and every 4 weeks for patients on dose levels 6 and 7 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies
Determine the toxicity profile of this drug in these patients
OUTLINE This is a dose-escalation study
Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1 Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3 Courses repeat every 2 weeks for patients on dose levels 1-5 and every 4 weeks for patients on dose levels 6 and 7 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
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-V01-1660 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068691 | REGISTRY | None | None |