Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243100
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2005-10-20
Brief Title:
Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of Suberoylanilide Hydroxamic Acid SAHA in Combination With Gemcitabine in Patients With Epithelial Tumors
Status:
COMPLETED
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:
This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine in treating patients with metastatic or unresectable solid tumors Drugs used in chemotherapy such as vorinostat and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity maximum tolerated dose and pharmacokinetics of vorinostat SAHA and gemcitabine in patients with metastatic or unresectable epithelial solid tumors
SECONDARY OBJECTIVES
II Determine tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation open-label study
Patients receive oral vorinostat SAHA once daily on days 1-14 and gemcitabine IV over 1-2 hours on days 3 and 10 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA 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 A minimum of 6 patients are treated at the MTD
After completion of study treatment patients are followed for 30 days
I Determine the dose-limiting toxicity maximum tolerated dose and pharmacokinetics of vorinostat SAHA and gemcitabine in patients with metastatic or unresectable epithelial solid tumors
SECONDARY OBJECTIVES
II Determine tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation open-label study
Patients receive oral vorinostat SAHA once daily on days 1-14 and gemcitabine IV over 1-2 hours on days 3 and 10 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SAHA 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 A minimum of 6 patients are treated at the MTD
After completion of study treatment patients are followed for 30 days
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 |
|---|---|---|---|
| U01CA062461 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062461 |
| NCI-2009-00091 | REGISTRY | None | None |
| CDR0000445401 | None | None | None |
| 2005-0140 | OTHER | None | None |
| 6865 | OTHER | None | None |