Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients

NCT ID: NCT02055560

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-18

Brief Summary

The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.

Detailed Description

This is a multi-center retrospective matched cohort study of early and late stage CRC patients who received 5-FU doses determined using body surface area (BSA) and in patients who underwent pharmacokinetically (PK)-guided 5-FU dose monitoring and adjustment. A retrospective chart / electronic medical record review of colorectal cancer patients treated with infusional 5-FU regimens between May 1, 2009 and December 31, 2013, satisfying the inclusion/exclusion criteria, will be performed. In this multi-center study, patients who underwent PK-testing during at least two different 5-FU administrations will be matched to patients who received doses based on their BSA, treated at the same institution. Matching for selection of the BSA cohort at each site will be done using the following criteria (based on factors that may influence 5-FU metabolism): age, gender, disease stage, prior chemotherapy treatment, and 5-FU containing treatment regimen being used. Each patient will be assigned a random five-digit Study ID number to protect patient confidentiality. Minimal medical history/demographics data will be collected from the patient's medical records / clinic chart using paper case report forms (CRFs). The data to be collected from each patient's records will include: patient demographics (i.e. gender, age, height, and race), colorectal cancer diagnosis (i.e. date of primary diagnosis, tumor stage, grade, histology and phenotype, and date of metastatic diagnosis and sites of metastases if applicable), use of prior therapies for treatment of CRC, 5-FU containing regimen details throughout the 5-FU treatment (i.e. weight, BSA, ECOG status, doses of each drug used in the regimen, and 5-FU infusion start/stop dates and times), 5-FU PK testing results (if applicable), concomitant procedures and medications, CBC and chemistry testing results, adverse events experienced during 5-FU therapy regimen, and tumor response and follow-up information. Patients will not be contacted for the purposes of this study and a waiver of HIPAA authorization will be requested from the appropriate IRB. Once data has been collected and monitored, all records tying the random Study ID number to a specific patient at the sites will be destroyed, rendering all information de-identified.

Conditions

Metastatic Colorectal Cancer; Adjuvant Colorectal Cancer; 5-FU Containing Therapy Regimens

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PK-Guided Cohort

CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was monitored and optimized using PK-guided dose adjustment.

No interventions assigned to this group

BSA Cohort

CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was done according to body surface area (BSA) and no PK monitoring was performed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male or female patients 18 years of age or older.
• Patients with histologically confirmed colorectal cancer who were treated with an infusional 5-FU regimen between May 1, 2009 and December 31, 2013.
• PK-Guided Cohort: Patients monitored with 5-FU PK-testing at a minimum of two administrations of 5-FU throughout the course of a single infusional 5-FU containing treatment regimen.
• BSA Cohort: Patients who received infusional 5-FU doses calculated based on their BSA.

Exclusion Criteria

• Patients less than 18 years of age.
• Patients with concurrent treatment of other active malignancies.
• Patients that underwent radiation therapy concurrently with chemotherapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saladax Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Miller, B.S.

Role: STUDY_DIRECTOR

Saladax Biomedical, Inc.

Locations

University of California San Diego

La Jolla, California, United States

Hematology/Oncology of the North Shore

Skokie, Illinois, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Tennessee Plateau Oncology

Crossville, Tennessee, United States

Texas Health Physicians Group

Plano, Texas, United States

Countries

United States

Other Identifiers

SBI-5FU-005

Identifier Type: -

Identifier Source: org_study_id