Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238225
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2005-10-12
Brief Title:
Calcitriol Ketoconazole and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of Oral Calcitriol in Combination With Ketoconazole in Refractory Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Calcitriol may cause solid tumor cells to look more like normal cells and to grow and spread more slowly Ketoconazole and dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug Giving calcitriol together with ketoconazole and dexamethasone may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of calcitriol when given together with ketoconazole and dexamethasone in treating patients with metastatic or unresectable solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of calcitriol when given together with ketoconazole and dexamethasone in treating patients with metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of calcitriol when administered with ketoconazole and dexamethasone in patients with metastatic or unresectable solid tumors
Secondary
Determine the tolerability and toxic effects of this regimen in these patients
Determine tumor response in patients treated with this regimen
Determine the pharmacokinetics of calcitriol and dexamethasone with or without ketoconazole in these patients
Determine the pharmacodynamics of this regimen in terms of CYP24 expression and activity and vitamin D receptor expression in peripheral blood mononuclear cells in these patients
OUTLINE This is a dose-escalation study of calcitriol
Patients receive oral dexamethasone twice daily beginning on day 0 and oral ketoconazole 3 times daily beginning on day 4 Patients also receive oral calcitriol once daily on days 1-3 of each week Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of calcitriol 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
After completion of study treatment patients are followed for up to 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of calcitriol when administered with ketoconazole and dexamethasone in patients with metastatic or unresectable solid tumors
Secondary
Determine the tolerability and toxic effects of this regimen in these patients
Determine tumor response in patients treated with this regimen
Determine the pharmacokinetics of calcitriol and dexamethasone with or without ketoconazole in these patients
Determine the pharmacodynamics of this regimen in terms of CYP24 expression and activity and vitamin D receptor expression in peripheral blood mononuclear cells in these patients
OUTLINE This is a dose-escalation study of calcitriol
Patients receive oral dexamethasone twice daily beginning on day 0 and oral ketoconazole 3 times daily beginning on day 4 Patients also receive oral calcitriol once daily on days 1-3 of each week Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of calcitriol 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
After completion of study treatment patients are followed for up to 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for 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 |
|---|---|---|---|
| RPCI-I-33204 | None | None | None |