Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC)
PRIMARY OBJECTIVES:
I. Determine the dose of suramin and fluorouracil that would result in plasma concentrations
of suramin between 10-50 uM in patients with metastatic renal cell cancer. (Phase I) II.
Determine the objective response rate (complete response and partial response) in patients
treated with this regimen. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the preliminary efficacy of this regimen in these patients. (Phase I) II.
Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) III.
Determine the time to tumor progression and progress rate at 3 and 6 months in patients
treated with this regimen. (Phase II)
OUTLINE: This is a dose-escalation phase I study followed by a phase II study.
PHASE I: Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15,
22, 29, and 36. Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil
until the dose level allowing 10-50 uM of suramin into the patient's blood is determined
without 2 or more of 6 patients experiencing dose-limiting toxicity.
PHASE II: Patients receive suramin and fluorouracil (at the dose level determined in phase
I) as in phase I.
In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease
progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I)
Up to 48 hours
No
Ronald Bukowski
Principal Investigator
The Cleveland Clinic
United States: Food and Drug Administration
NCI-2012-02586
NCT00083109
March 2004
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |