Stage IV Breast Cancer Clinical Trial
Official title:
A Phase 2 Study of GTI-2040 (NSC 722929) in Combination With Capecitabine in Metastatic Breast Cancer
This phase II trial is studying how well giving GTI-2040 together with capecitabine works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to the drug
PRIMARY OBJECTIVES:
I. To evaluate the response rate and response duration to combination therapy with GTI-2040
and capecitabine in the treatment of metastatic breast cancer.
II. To safely evaluate the toxicity of this drug combination and schedule in this patient
population by first using a lower dose followed by escalation.
III. To determine pharmacokinetic data on plasma levels of GTI-2040 in this patient
population.
IV. To investigate potential molecular markers of ribonucleotide reductase inhibition and
fluoropyrimidine metabolism in this patient population treated with the combination of
GTI-2040 and capecitabine.
OUTLINE: This is a multicenter study.
Patients receive GTI-2040 IV continuously on days 1-15 of the first course and days 1-14 of
all subsequent courses. Patients also receive oral capecitabine twice daily on days 2-15.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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