Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072228
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2003-11-04
Brief Title:
Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Daiichi Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 such as soblidotin and gemcitabine 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 This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors
Determine the dose-limiting toxic effects of this regimen in these patients
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for survival every 3 months after completion of study therapy
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 1 year
Primary
Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors
Determine the dose-limiting toxic effects of this regimen in these patients
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for survival every 3 months after completion of study therapy
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCT00072228 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000339345 | REGISTRY | None | None |
| CPMC-IRB-20031085 | None | None | None |