Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02569723|
Recruitment Status : Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : August 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colon Adenocarcinoma||Drug: Carbon C 14 Oxaliplatin Drug: Oxaliplatin||Not Applicable|
I. To evaluate the feasibility of [14C] (carbon C 14) oxaliplatin microdose as a clinical assay to predict oxaliplatin exposure.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of a Carbon 14 Oxaliplatin Microdosing Assay to Predict Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy in Advanced Colorectal Cancer|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||April 20, 2018|
|Estimated Study Completion Date :||July 2021|
Experimental: carbon C 14 oxaliplatin and oxaliplatin
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 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.
Drug: Carbon C 14 Oxaliplatin
Other Name: [14C] Oxaliplatin
Other Name: Eloxatin
- Feasibility of 14C Oxaliplatin Microdose as a clinical assay to predict oxaliplatin exposure [ Time Frame: 0-5 minutes predose, 5, 15, and 30 minutes, and at 1, 2, 4, 8, and 24 hours after carbon C 14 oxaliplatin microdose ]Correlate area under curve from phase 0 microdosing with area under curve for therapeutic dose of oxaliplatin
- Duration of disease control (DDC) according to RECIST 1.1 [ Time Frame: Up to 2 years ]Will characterize the repair of DNA adducts in PBMC, using descriptive statistics.
- Incidence of adverse events according to the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 2 years ]Assess toxicity to both microdoses of carbon C 14 oxaliplatin. Toxicities potentially related to carbon C 14 oxaliplatin will be assessed from initiation of the study to at least 14 days after the administration of the FOLFOX-integrated microdose or until full recover of toxicity (whichever is longer). Safety will be assessed through summaries of adverse events and laboratory evaluations.
- Response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 2 years ]Will characterize the repair of DNA adducts in peripheral blood mononuclear cell (PBMC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569723
|United States, California|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Edward Kim||University of California, Davis|