Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003038
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-08
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with suramin plus doxorubicin in treating patients with advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with suramin plus doxorubicin in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of suramin followed by doxorubicin in patients with advanced solid tumors II Describe the toxic effects of suramin with sequential doses of doxorubicin in these patients III Assess the development of peripheral neuropathy in patients with this treatment IV Assess the preliminary evidence of the antitumor effect of this regimen in these patients VI Explore the relationships between the pharmacokinetic parameters and potential neurotoxicity of suramin in these patients
OUTLINE This is a dose-escalation study of doxorubicin Patients receive suramin IV daily over 1-2 hours on days 1-4 followed by doxorubicin IV over 10-15 minutes on day 5 Treatment repeats every 4 weeks for up to 3 courses in the absence of unacceptable toxicity disease progression or clinical deterioration Starting from course 4 patients receive alternating courses of doxorubicin IV on day 1 every 4 weeks courses 4 6 8 etc and suramin with doxorubicin courses 5 7 9 etc as described above Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Stable patients who achieve disease response and are able to receive a target cumulative dose of doxorubicin may discontinue doxorubicin and receive suramin alone every 8 weeks Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study within 1 year
OUTLINE This is a dose-escalation study of doxorubicin Patients receive suramin IV daily over 1-2 hours on days 1-4 followed by doxorubicin IV over 10-15 minutes on day 5 Treatment repeats every 4 weeks for up to 3 courses in the absence of unacceptable toxicity disease progression or clinical deterioration Starting from course 4 patients receive alternating courses of doxorubicin IV on day 1 every 4 weeks courses 4 6 8 etc and suramin with doxorubicin courses 5 7 9 etc as described above Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Stable patients who achieve disease response and are able to receive a target cumulative dose of doxorubicin may discontinue doxorubicin and receive suramin alone every 8 weeks Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 20 patients will be accrued for this study within 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 |
|---|---|---|---|
| 960105 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |