Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070239
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2003-10-03
Brief Title:
Alvocidib in Treating Patients With Metastatic or Unresectable Refractory Solid Tumors or Hematologic Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical Pharmacokinetic and Pharmacodynamic Study of Flavopiridol in Patients With Refractory Solid Tumors and Hematologic Malignancies
Status:
TERMINATED
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:
This phase I trial is studying the side effects and best dose of alvocidib in treating patients with metastatic or unresectable refractory solid tumors or hematologic malignancies Drugs used in chemotherapy such as alvocidib work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVE
I Determine the maximum tolerated dose of flavopiridol in patients with metastatic or unresectable refractory solid tumors or hematologic malignancies Accrual for patients with hematologic malignancies temporarily closed as of 113004
SECONDARY OBJECTIVES
I Determine the safety profile and toxic effects of this drug in these patients
II Determine the pharmacokinetics of this drug in these patients III Determine by pharmacodynamic assays the ability of this drug to inhibit cyclin-dependent kinase activity in tumor tissue normal proliferating tissues circulating tumor cells and in plasma in these patients
IV Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a 2-part dose-escalation multicenter study
PART 1 closed to accrual as of 82005 Patients receive alvocidib IV over 1 hour on days 1 8 and 15
Cohorts of 3-6 patients receive escalating doses of alvocidib until the maximum tolerated dose MTD is determined
PART 2 Patients receive alvocidib IV over 1 hour at or below the MTD determined in part 1 and then receive a maintenance dose of alvocidib IV over 1-6 hours on days 1 8 and 15 Cohorts of 3-6 patients receive escalating durations of the maintenance dose of alvocidib until the MTD is determined An additional cohort of 10-20 patients receives alvocidib over 1 hour on days 1 and 15 at the MTD
NOTE The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
In both parts courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month and then every 2 months thereafter
I Determine the maximum tolerated dose of flavopiridol in patients with metastatic or unresectable refractory solid tumors or hematologic malignancies Accrual for patients with hematologic malignancies temporarily closed as of 113004
SECONDARY OBJECTIVES
I Determine the safety profile and toxic effects of this drug in these patients
II Determine the pharmacokinetics of this drug in these patients III Determine by pharmacodynamic assays the ability of this drug to inhibit cyclin-dependent kinase activity in tumor tissue normal proliferating tissues circulating tumor cells and in plasma in these patients
IV Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a 2-part dose-escalation multicenter study
PART 1 closed to accrual as of 82005 Patients receive alvocidib IV over 1 hour on days 1 8 and 15
Cohorts of 3-6 patients receive escalating doses of alvocidib until the maximum tolerated dose MTD is determined
PART 2 Patients receive alvocidib IV over 1 hour at or below the MTD determined in part 1 and then receive a maintenance dose of alvocidib IV over 1-6 hours on days 1 8 and 15 Cohorts of 3-6 patients receive escalating durations of the maintenance dose of alvocidib until the MTD is determined An additional cohort of 10-20 patients receives alvocidib over 1 hour on days 1 and 15 at the MTD
NOTE The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
In both parts courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month and then every 2 months thereafter
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-2009-00039 | REGISTRY | None | None |
| 03-082 | None | None | None |
| P 6052 | None | None | None |
| CDR0000331689 | None | None | None |
| 03-082 | OTHER | None | None |
| 6052 | OTHER | None | None |
| U01CA062490 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062490 |