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RATIONALE: 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.
- Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 µM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer.
- Determine the pharmacokinetics of low-dose suramin in these patients.
- Determine the objective response rate in patients treated with this regimen.
- Determine the time to tumor progression in patients treated with this regimen.
- Determine the 1-year survival of patients treated with this regimen.
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 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 µM 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.
Primary Purpose: Treatment
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:29-0400
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