Stage IV Breast Cancer Clinical Trial
Official title:
A Phase I/II Study of Suramin in Combination With Paclitaxel in Advanced (Stage IIIB or IV) Metastatic Breast Cancer
This phase I/II 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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