Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003249
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
1999-11-01
Brief Title:
Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Investigation of Carboxyamido-triazole CAI Modulated by Ketoconozole In Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating patients with advanced cancers Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of carboxyamidotriazole CAI in combination with ketoconazole in patients with advanced malignancies
II Evaluate the toxic effects safety and efficacy of CAI in combination with ketoconazole
III Determine the modulatory effects of ketoconazole on the pharmacokinetic profile of CAI
IV Determine a pharmacodynamic model for CAI and ketoconazole with respect to potential gastrointestinal hematologic and neurotoxicities
OUTLINE This is a dose escalation study
Patients receive oral carboxyamidotriazole CAI as a test dose on day 1 Patients receive oral ketoconazole on day 7 followed by CAI plus ketoconazole on day 8 CAI and ketoconazole are administered in combination on day 1 and days 3-28 of the first course Ketoconazole is administered alone on day 2 of the first course Subsequent courses begin at 28 day intervals in the absence of disease progression or unacceptable toxic effects Cohorts of 3 patients are evaluated at each dose level prior to dose escalation If one of three patients within a cohort experiences dose limiting toxicity DLT that dose level is expanded to incorporate six patients If two or more patients experience DLT the next lower dose is declared to be the maximum tolerated dose
I Determine the maximum tolerated dose of carboxyamidotriazole CAI in combination with ketoconazole in patients with advanced malignancies
II Evaluate the toxic effects safety and efficacy of CAI in combination with ketoconazole
III Determine the modulatory effects of ketoconazole on the pharmacokinetic profile of CAI
IV Determine a pharmacodynamic model for CAI and ketoconazole with respect to potential gastrointestinal hematologic and neurotoxicities
OUTLINE This is a dose escalation study
Patients receive oral carboxyamidotriazole CAI as a test dose on day 1 Patients receive oral ketoconazole on day 7 followed by CAI plus ketoconazole on day 8 CAI and ketoconazole are administered in combination on day 1 and days 3-28 of the first course Ketoconazole is administered alone on day 2 of the first course Subsequent courses begin at 28 day intervals in the absence of disease progression or unacceptable toxic effects Cohorts of 3 patients are evaluated at each dose level prior to dose escalation If one of three patients within a cohort experiences dose limiting toxicity DLT that dose level is expanded to incorporate six patients If two or more patients experience DLT the next lower dose is declared to be the maximum tolerated dose
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 |
|---|---|---|---|
| CDR0000066129 | REGISTRY | PDQ Physician Data Query | None |
| UCCRC-9019 | None | None | None |
| NCI-T97-0086 | None | None | None |