Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054028
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2003-02-05
Brief Title:
Suramin and Paclitaxel in Treating Women With Stage IIIB-IV Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Suramin in Combination With Paclitaxel in Advanced Stage IIIB or IV Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This phase III trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Suramin may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose of suramin in combination with paclitaxel TXT that results in suramin plasma concentrations approaching 10-50 uM over the duration when TXT in the plasma is at therapeutically significant levels in women with stage IIIB or IV breast cancer Phase I II Determine the objective response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of low-dose suramin in these patients Phase I II Determine the time to tumor progression in patients treated with this regimen Phase II III Determine the 1-year survival of patients treated with this regimen Phase II
OUTLINE This is a phase I dose-escalation study of suramin followed by a phase II multicenter study
PHASE I Patients receive low-dose suramin intravenously IV over 30 minutes and paclitaxel IV over 1 hour once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic
PHASE II Patients receive paclitaxel in combination with the target dose of suramin as above
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for the phase I study within 9 months A total of 28 patients will be accrued for the phase II study within 18-24 months
I Determine the dose of suramin in combination with paclitaxel TXT that results in suramin plasma concentrations approaching 10-50 uM over the duration when TXT in the plasma is at therapeutically significant levels in women with stage IIIB or IV breast cancer Phase I II Determine the objective response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of low-dose suramin in these patients Phase I II Determine the time to tumor progression in patients treated with this regimen Phase II III Determine the 1-year survival of patients treated with this regimen Phase II
OUTLINE This is a phase I dose-escalation study of suramin followed by a phase II multicenter study
PHASE I Patients receive low-dose suramin intravenously IV over 30 minutes and paclitaxel IV over 1 hour once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic
PHASE II Patients receive paclitaxel in combination with the target dose of suramin as above
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for the phase I study within 9 months A total of 28 patients will be accrued for the phase II study within 18-24 months
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 |
|---|---|---|---|
| 0216 | None | None | None |
| OSU-02H0216 | None | None | None |
| OSU-0216 | None | None | None |
| NCI-5851 | None | None | None |
| CDR0000269707 | None | None | None |
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |