Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098579
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2004-12-07
Brief Title:
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Doxorubicin and Alvocidib Flavopiridol NCI Supplied Agent NSC 649890 in the Treatment of Metastatic Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-03
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 when given with doxorubicin hydrochloride in treating patients with metastatic or recurrent sarcoma that cannot be removed by surgery Drugs used in chemotherapy such as doxorubicin hydrochloride and alvocidib work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Alvocidib may also help doxorubicin hydrochloride work better by making tumor cells more sensitive to the drug Giving more than one drug may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVE
I Determine the maximum tolerated dose of flavopiridol alvocidib when administered with a fixed dose of doxorubicin doxorubicin hydrochloride in patients with unresectable metastatic or locally recurrent sarcoma
SECONDARY OBJECTIVES
I Determine the clinical pharmacokinetics of this regimen in these patients II Determine preliminarily the therapeutic activity of this regimen in these patients
III Correlate pRb p53 and p21 protein levels with treatment response and apoptosis in patients treated with this regimen
IV Correlate NMR biochemical patterns with response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of alvocidib
Patients receive doxorubicin hydrochloride intravenously IV over 5-10 minutes and alvocidib IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients reaching a cumulative doxorubicin dose of 600 mgm2 or experiencing cardiotoxicity may receive alvocidib alone at the discretion of the investigator Cohorts of 3-6 patients receive escalating doses of alvocidib 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 Ten additional patients receive treatment at the MTD Patients are followed every 3 months for 1 year
I Determine the maximum tolerated dose of flavopiridol alvocidib when administered with a fixed dose of doxorubicin doxorubicin hydrochloride in patients with unresectable metastatic or locally recurrent sarcoma
SECONDARY OBJECTIVES
I Determine the clinical pharmacokinetics of this regimen in these patients II Determine preliminarily the therapeutic activity of this regimen in these patients
III Correlate pRb p53 and p21 protein levels with treatment response and apoptosis in patients treated with this regimen
IV Correlate NMR biochemical patterns with response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation study of alvocidib
Patients receive doxorubicin hydrochloride intravenously IV over 5-10 minutes and alvocidib IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients reaching a cumulative doxorubicin dose of 600 mgm2 or experiencing cardiotoxicity may receive alvocidib alone at the discretion of the investigator Cohorts of 3-6 patients receive escalating doses of alvocidib 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 Ten additional patients receive treatment at the MTD Patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |
| 04-075A | None | None | None |