Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331955
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2006-05-30
Brief Title:
Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Vorinostat NSC-701852 Suberoylanilide Hydroxamic Acid and Doxorubicin NSC-123127 Adriamycin
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This phase I trial is studying the side effects and best dose of vorinostat when given together with doxorubicin in treating patients with metastatic or locally advanced solid tumors Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may help doxorubicin work better by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of vorinostat SAHA and doxorubicin hydrochloride in patients with metastatic or locally advanced solid tumors
II Determine the maximum tolerated dose of vorinostat when administered with doxorubicin hydrochloride in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the response rate complete response CR and partial response PR and clinical benefits rate CR PR and stable disease 12 weeks in patients treated with this regimen
II Determine the pharmacokinetics and pharmacodynamics of vorinostat and doxorubicin hydrochloride and their interaction
III Determine the effects of vorinostat on histone acetylation in peripheral blood mononuclear cells and tumors
IV Determine the effects of vorinostat on DNA damage induced by doxorubicin hydrochloride as a function of topoisomerase II expression
V Determine the effects of vorinostat on genes and proteins crucial for the maintenance of chromatin structure
OUTLINE This is a non-randomized open-label dose-escalation study of vorinostat
Patients receive oral vorinostat twice daily for 5 doses on days 1-3 8-10 and 15-17 and doxorubicin hydrochloride IV on days 3 10 and 17 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 6 courses of treatment may continue to receive vorinostat alone in the absence of disease progression
Cohorts of 3-6 patients receive escalating doses of vorinostat 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 Up to15 patients are treated at the MTD Mandatory biopsies are required in these patients Patients undergo blood collection and tumor biopsies periodically during the study for pharmacologic pharmacokinetic pharmacodynamic and biomarker correlative studies
After completion of study treatment patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued to this study
I Determine the safety and tolerability of vorinostat SAHA and doxorubicin hydrochloride in patients with metastatic or locally advanced solid tumors
II Determine the maximum tolerated dose of vorinostat when administered with doxorubicin hydrochloride in patients treated with this regimen
SECONDARY OBJECTIVES
I Determine the response rate complete response CR and partial response PR and clinical benefits rate CR PR and stable disease 12 weeks in patients treated with this regimen
II Determine the pharmacokinetics and pharmacodynamics of vorinostat and doxorubicin hydrochloride and their interaction
III Determine the effects of vorinostat on histone acetylation in peripheral blood mononuclear cells and tumors
IV Determine the effects of vorinostat on DNA damage induced by doxorubicin hydrochloride as a function of topoisomerase II expression
V Determine the effects of vorinostat on genes and proteins crucial for the maintenance of chromatin structure
OUTLINE This is a non-randomized open-label dose-escalation study of vorinostat
Patients receive oral vorinostat twice daily for 5 doses on days 1-3 8-10 and 15-17 and doxorubicin hydrochloride IV on days 3 10 and 17 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with responding or stable disease after 6 courses of treatment may continue to receive vorinostat alone in the absence of disease progression
Cohorts of 3-6 patients receive escalating doses of vorinostat 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 Up to15 patients are treated at the MTD Mandatory biopsies are required in these patients Patients undergo blood collection and tumor biopsies periodically during the study for pharmacologic pharmacokinetic pharmacodynamic and biomarker correlative studies
After completion of study treatment patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued to this study
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 |
|---|---|---|---|
| R21CA112913 | NIH | None | httpsreporternihgovquickSearchR21CA112913 |
| MCC 14193 | None | None | None |
| CDR0000471997 | None | None | None |
| NCI-6970 | None | None | None |
| MCC-IRB-103476 | None | None | None |