Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008086
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2001-01-06
Brief Title:
Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase I Trial of Subcutaneous AndOr Oral Calcitriol 125-COH2D3 and Carboplatin in Advanced Solid 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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Calcitriol may help solid tumor cells develop into normal cells Combining calcitriol with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated doses of calcitriol and carboplatin when given in combination in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Determine the effect of calcitriol on the pharmacokinetics of carboplatin in these patients
Correlate the pharmacokinetics of carboplatin with the myelosuppression following this regimen in these patients
Determine the safety and efficacy of this regimen in patients with malignant glioma
OUTLINE This is a dose-escalation study Patients are stratified according to disease brain tumor vs other solid tumor and accrued in parallel Patients are assigned to one of two treatment groups
Group 1 Patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol subcutaneously SC or orally daily on days 2-4 for the first course only For subsequent courses patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3
Group 2 Patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3 for the first third and subsequent courses For the second course only patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol SC or orally daily on days 2-4
In both groups treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of calcitriol is followed by sequential dose escalation of carboplatin Cohorts of 3-6 patients receive escalating doses of calcitriol and then carboplatin until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 18-50 patients will be accrued for this study
Determine the maximum tolerated doses of calcitriol and carboplatin when given in combination in patients with advanced solid tumors
Determine the toxic effects of this regimen in these patients
Determine the effect of calcitriol on the pharmacokinetics of carboplatin in these patients
Correlate the pharmacokinetics of carboplatin with the myelosuppression following this regimen in these patients
Determine the safety and efficacy of this regimen in patients with malignant glioma
OUTLINE This is a dose-escalation study Patients are stratified according to disease brain tumor vs other solid tumor and accrued in parallel Patients are assigned to one of two treatment groups
Group 1 Patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol subcutaneously SC or orally daily on days 2-4 for the first course only For subsequent courses patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3
Group 2 Patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3 for the first third and subsequent courses For the second course only patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol SC or orally daily on days 2-4
In both groups treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of calcitriol is followed by sequential dose escalation of carboplatin Cohorts of 3-6 patients receive escalating doses of calcitriol and then carboplatin until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 18-50 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 |
|---|---|---|---|
| NCI-G00-1885 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068374 | REGISTRY | None | None |
| PCI-IRB-970532 | None | None | None |