Oxaliplatin in Treating Patients With Metastatic Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title: A Diagnostic Feasibility Trial of a [14C]Oxaliplatin Microdosing Assay for Prediction of Chemoresistance to Oxaliplatin Chemotherapy

Status Completed

Clinical Trial Summary

This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood and the side effects and how well oxaliplatin works in treating patients with metastatic breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon C 14 oxaliplatin may help doctors predict how well patients will respond to treatment with oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To detect the levels of oxaliplatin-deoxyribonucleic acid (DNA) adducts induced by oxaliplatin microdosing in tumor tissue and peripheral blood mononuclear cells (PBMC), and correlate the results with patient response to oxaliplatin-based chemotherapy.

SECONDARY OBJECTIVES:

I. Evaluate the efficacy of single agent oxaliplatin treatment (130mg/m^2, 2 hr intravenously [IV] day 1; every 3 weeks) in pre-treated, metastatic breast cancer patients.

II. Evaluate the toxicity of oxaliplatin microdose and chemotherapy treatment in this patient population.

III. Determine the pharmacokinetic (PK) parameters of oxaliplatin microdosing and correlate with the PK parameters of therapeutic oxaliplatin.

IV. Determine whether the pharmacokinetics of oxaliplatin microdosing affects oxaliplatin-induced DNA damage and, therefore, patient response to chemotherapy.

V. Detect repair of DNA adducts in PBMC and correlate with patient response to oxaliplatin-based chemotherapy.

VI. Correlate the adduct and patient response data to DNA repair genes, such as excision repair cross-complementing (ERCC)1 levels as measured by reverse transcriptase-polymerase chain reaction (RT-PCR).

OUTLINE:

PHASE 0: Patients receive carbon C 14 oxaliplatin IV over 2 minutes on day 1.

PHASE II: Patients receive oxaliplatin IV over 2 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 6 months. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV Breast Cancer

• NCT number: NCT02077998
• Study type: Interventional
• Source: University of California, Davis
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2015
• Completion date: December 2015