NCT02569723

Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy

Pilot Study of a Carbon 14 Oxaliplatin Microdosing Assay to Predict Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy in Advanced Colorectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Edward Kim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well carbon C 14 oxaliplatin microdosing assay works in predicting exposure and sensitivity to oxaliplatin-based chemotherapy in patients with colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carbon C 14 is a radioactive form of carbon, exists in nature and in the body at a low level. Microdose carbon C 14 oxaliplatin diagnostic assay may help doctors understand how well patients respond to treatment and develop individualize oxaliplatin dosing in patients with colorectal cancer.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the feasibility of \[14C\] (carbon C 14) oxaliplatin microdose as a clinical assay to predict oxaliplatin exposure. SECONDARY OBJECTIVES: I. To estimate the degree to which a \[14C\]oxaliplatin microdose predicts the observed pharmacokinetics of standard dose oxaliplatin. II. To validate that intrapatient variation of exposure to a \[14C\]oxaliplatin microdose is less than 5%. III. To detect the levels of oxaliplatin-deoxyribonucleic acid (DNA) adducts induced by oxaliplatin microdosing in peripheral blood mononuclear cells (PBMCs), and correlate the results with patient response and progression free survival on oxaliplatin-based chemotherapy. IV. To develop preliminary safety data of \[14C\]oxaliplatin microdosing for future studies. OUTLINE: Patients receive carbon C 14 oxaliplatin microdose intravenously (IV) over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

• Colon Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Carbon C 14 Oxaliplatin	Intravenous infusion
DRUG	Oxaliplatin	Intravenous infusion

Timeline

• Start date: 2015-10-16
• Primary completion: 2018-04-20
• Completion: 2020-04-04
• First posted: 2015-10-07
• Last updated: 2021-03-30
• Results posted: 2021-03-30

Locations

1 site across 1 country: United States