Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246103
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-10-28
Brief Title:
Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2009-01
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 is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose escalation step of epirubicin VPA will be escalated starting at a dose that is recommended for use as an anti-convulsant or to treat migraine headaches Epirubicin will be given by infusion on day 3 after the last dose of divalproex The study will determine the highest dose that these two drugs can be given together and as part of a multidrug regimen with 5-fluorouracil and cyclophosphamide
Detailed Description:
This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose escalation step of epirubicin VPA will be escalated starting at a dose that is recommended for use as an anti-convulsant or to treat migraine headaches Recommended concentrations for seizure control is 15-60 mgkg Pharmacokinetic studies from healthy volunteers and patients suggested a linear increase in plasma concentrations A daily dosing of 16 mgkg divalproex delayed-release VPA resulted in a peak VPA plasma concentration of 127 μgml 09 mM 27 The recommended Phase II dose of VPA was 60 mgkgd when given by a one-hour intravenous infusion twice daily for 5 days every three weeks
Synergistic activity between VPA and epirubicin has been observed at 05 mM of VPA in our preclinical laboratory studies Patients will receive an intravenous loading dose of VPA followed by divalproex in two daily doses for 5 doses The loading dose of VPA will avoid a delay in peak plasma concentrations and excessive nausea Epirubicin will be given by infusion on day 3 after the last dose of divalproex
Once the MTD for this two drug regimen has been determined the maximum tolerated dose will be determined as part of the FEC regimen 5-fluorouracil epirubicin and cyclophosphamide
Synergistic activity between VPA and epirubicin has been observed at 05 mM of VPA in our preclinical laboratory studies Patients will receive an intravenous loading dose of VPA followed by divalproex in two daily doses for 5 doses The loading dose of VPA will avoid a delay in peak plasma concentrations and excessive nausea Epirubicin will be given by infusion on day 3 after the last dose of divalproex
Once the MTD for this two drug regimen has been determined the maximum tolerated dose will be determined as part of the FEC regimen 5-fluorouracil epirubicin and cyclophosphamide
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 |
|---|---|---|---|
| USFIRB101881 | None | None | None |