A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors
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.
Primary Purpose: Treatment
Alex A. Adjei, MD, PhD
United States: Federal Government
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