Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of California, Davis
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
