NCT00068588

GTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer

A Phase 2 Study of GTI-2040 (NSC 722929) in Combination With Capecitabine in Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GTI-2040	Given IV
DRUG	capecitabine	Given orally

Timeline

• Start date: 2003-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2003-09-11
• Last updated: 2014-10-31
• Results posted: 2014-10-31

Locations

1 site across 1 country: United States