Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients

NCT02055560 | Completed

• 1 other identifier: SBI-5FU-005
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

colorectal; OnDose; MyCare; 5-FU; pharmacokinetics; exposure; optimization; dose adjustment

Outcome Measures

Primary Outcomes (5)

• Variability of 5-FU plasma levels (exposure)

  At each treatment cycle (i.e. Cycle 1, Cycle 2, Cycle 3, etc.), we will plot the 5-FU exposure (i.e. AUC value) and determine the average, median, standard deviation, and percent coefficient of variation (%CV). These statistics will also be determined for all 5-FU exposure values combined.

  At each cycle after initiation of 5-FU containing therapy, or approximately every 1 - 2 weeks, depending on the 5-FU infusion schedule, for up to ~12 cycles (~24 weeks) total.

• Hematological and non-hematological toxicity rates

  Incidence of 5-FU related toxicities, such as diarrhea, oral mucositis, neutropenia, anemia, febrile neutropenia, thrombocytopenia, nausea, etc., will be recorded throughout the duration of the 5-FU containing therapy regimen.

  From initiation of the 5-FU containing therapy until up to 30 days after its discontinuation, or for up to ~28 weeks total

• Tumor response

  Tumor response rates as determined by imaging \[classified as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)\].

  At each follow-up disease assessment following initiation of 5-FU containing thearpy, expected to occur an average of every 8 - 12 weeks, until discontinuation of therapy, or up to ~24 weeks total.

• Progression-free survival (PFS)

  up to 3.5 years after initiation of 5-FU containing therapy regimen

• Overall survival

  up to 3.5 years after initiation of 5-FU containing therapy regimen

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients treated with 5-FU containing therapy regimens by US based oncologists in community and academic setting. Sites which ordered \>20 Myriad OnDose tests in 2012 will be approached for participation in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saladax Biomedical, Inc.: lead

Study Sites (5)

University of California San Diego

La Jolla, California, 92093, United States

Location

Hematology/Oncology of the North Shore

Skokie, Illinois, 60076, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Tennessee Plateau Oncology

Crossville, Tennessee, 38555, United States

Location

Texas Health Physicians Group

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Craig Miller, B.S.

  Saladax Biomedical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 5, 2014
• Study Start: January 1, 2014
• Primary Completion: April 2, 2015
• Study Completion: December 18, 2015
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)