Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121277
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2005-07-19
Brief Title:
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Study of Suberoylanilide Hydroxamic Acid SAHA in Combination With Capecitabine in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-07
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 vorinostat and capecitabine 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 Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vorinostat and capecitabine in treating patients with unresectable or metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of vorinostat and capecitabine in treating patients with unresectable or metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of vorinostat SAHA and capecitabine in patients with metastatic or unresectable solid tumors
Determine the safety and tolerability of this regimen in these patients
Secondary
Correlate the clinical effects with the pharmacokinetic effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral vorinostat SAHA once or twice daily and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses beyond documentation of CR Patients achieving a partial response receive 2 courses beyond documentation of best response
Cohorts of 3-6 patients receive escalating doses of SAHA and capecitabine 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 An additional 12 patients are treated at the MTD
After completion of study treatment patients are followed at 3-4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 18-30 patients will be accrued for this study within 6-10 months
Primary
Determine the maximum tolerated dose and recommended phase II dose of vorinostat SAHA and capecitabine in patients with metastatic or unresectable solid tumors
Determine the safety and tolerability of this regimen in these patients
Secondary
Correlate the clinical effects with the pharmacokinetic effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral vorinostat SAHA once or twice daily and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 courses beyond documentation of CR Patients achieving a partial response receive 2 courses beyond documentation of best response
Cohorts of 3-6 patients receive escalating doses of SAHA and capecitabine 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 An additional 12 patients are treated at the MTD
After completion of study treatment patients are followed at 3-4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 18-30 patients will be accrued for this study within 6-10 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-6868 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000434850 | REGISTRY | None | None |