Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006372
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-10-04
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Trial of Combination Pegylated Liposomal Doxorubicin Doxil Vinorelbine and Gemcitabine
Status:
COMPLETED
Status Verified Date:
2010-06
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 combination chemotherapy in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the pharmacokinetic profile of gemcitabine doxorubicin HCl liposome and vinorelbine in patients with advanced solid tumors
Determine the maximum tolerated dose of this regimen in these patients
Determine the toxicity profile of this regimen in these patients
OUTLINE This is a dose escalation study
Patients receive doxorubicin HCl liposome IV over 1-25 hours on day 1 gemcitabine IV over 30 minutes on days 1 and 8 and vinorelbine IV over 6-10 minutes on days 1 and 15 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome gemcitabine and vinorelbine 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 every 3 months for up to 1 year
PROJECTED ACCRUAL Approximately 9-24 patients will be accrued for this study within 12-18 months
Determine the pharmacokinetic profile of gemcitabine doxorubicin HCl liposome and vinorelbine in patients with advanced solid tumors
Determine the maximum tolerated dose of this regimen in these patients
Determine the toxicity profile of this regimen in these patients
OUTLINE This is a dose escalation study
Patients receive doxorubicin HCl liposome IV over 1-25 hours on day 1 gemcitabine IV over 30 minutes on days 1 and 8 and vinorelbine IV over 6-10 minutes on days 1 and 15 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome gemcitabine and vinorelbine 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 every 3 months for up to 1 year
PROJECTED ACCRUAL Approximately 9-24 patients will be accrued for this study within 12-18 months
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-G00-1859 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-1Y99 | None | None | None |