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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00083109
Other study ID # NCI-2012-02586
Secondary ID NCI-2012-02586CC
Status Completed
Phase Phase 1/Phase 2
First received May 14, 2004
Last updated May 22, 2015
Start date March 2004
Est. completion date March 2008

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Fluorouracil
Given IV
Other:
Pharmacological Study
Correlative studies
Drug:
Suramin
Given IV

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose of suramin to deliver the target plasma concentrations of 10 to 50 uM (Phase I) Up to 48 hours No
Primary Objective response rate (CR + PR) using RECIST criteria (Phase II) Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data. Up to 4 years No
Secondary Progression rate (Phase II) Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data. 3 months No
Secondary Progression rate (Phase II) Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data. 6 months No
Secondary Time to disease progression (Phase II) Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data. Up to 4 years No
Secondary Toxicity assessed using NCI CTCAE version 3.0 (Phase II) Summary statistics (e.g. means and standard deviations or medians and ranges, or frequency counts) and 95% confidence intervals will be calculated. Graphical models will also be used to summarize the data. Up to 4 years Yes
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