Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036790
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2002-05-13
Brief Title:
Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2015-09
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 Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies
Determine the dose-limiting toxicity of this regimen in these patients
Determine the safety and tolerability of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Evaluate the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 2 groups
Group A
Course 1 Patients receive motexafin gadolinium IV over 30 minutes on days 1 8 9 and 10 and doxorubicin IV over 15 minutes on day 8
Course 2 28 days after the beginning of course 1 patients receive doxorubicin IV over 15 minutes
Courses 3-6 Beginning 21 days after course 2 patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3 Treatment repeats every 21 days
Group B
Course 1 Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8
Course 2 28 days after the beginning of course 1 patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3
Courses 3-6 Beginning 21 days after course 2 patients receive doxorubicin and motexafin gadolinium as in group A
Treatment in both groups continues for up to 6 courses in the absence of disease progression unacceptable toxicity or a cumulative doxorubicin dose of 450 mgm2
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 months
PROJECTED ACCRUAL A total of 3-48 patients will be accrued for this study
Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies
Determine the dose-limiting toxicity of this regimen in these patients
Determine the safety and tolerability of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Evaluate the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 2 groups
Group A
Course 1 Patients receive motexafin gadolinium IV over 30 minutes on days 1 8 9 and 10 and doxorubicin IV over 15 minutes on day 8
Course 2 28 days after the beginning of course 1 patients receive doxorubicin IV over 15 minutes
Courses 3-6 Beginning 21 days after course 2 patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3 Treatment repeats every 21 days
Group B
Course 1 Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8
Course 2 28 days after the beginning of course 1 patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3
Courses 3-6 Beginning 21 days after course 2 patients receive doxorubicin and motexafin gadolinium as in group A
Treatment in both groups continues for up to 6 courses in the absence of disease progression unacceptable toxicity or a cumulative doxorubicin dose of 450 mgm2
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 and 2 months
PROJECTED ACCRUAL A total of 3-48 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-G02-2061 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-01910 | None | None | None |
| PCI-PCYC-0207 | None | None | None |