Association of Capecitabine Pharmacokinetics and Toxicity With Aging

NCT03465202 | Unknown Phase 4 DMC

• 1 other identifier: SBRU201501
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-centre prospective non-interventional study designed to evaluate the effects of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR, and 5-FU. In addition, the study will assess the correlation between the pharmacokinetic parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty, treatment outcome, and toxicity. To be enrolled, patients must have breast or colorectal cancer and be eligible to receive capecitabine monotherapy in accordance with its approved clinical usage in the UK. Treatment will be administered according to NICE guidelines as well as the clinical judgement of the prescribing physician. One hundred patients (50 breast cancer patients, 50 colorectal cancer patients) who are about to start treatment with capecitabine monotherapy will be recruited to the study and undergo study procedures within the first week of treatment.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Capecitabine; Pharmacokinetics; Ageing; Frailty; Breast cancer; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of capecitabine and metabolites

  Measurement of AUC of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.

  0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose

Secondary Outcomes (10)

• Toxicities and grades as scaled by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03

  Six months

• Progression free survival as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1

  From time of enrollment until first documented progression

• Response as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1

  From time of enrollment to first documented response

• Grip strength measured in kg

  During 6-hour pharmacokinetic study session

• Frailty as measured by the Edmonton Frail Scale

  During 6-hour pharmacokinetic study session

Study Arms (1)

Capecitabine

EXPERIMENTAL

Drug: Capecitabine

Interventions

Capecitabine DRUG

Also known as: Xeloda

Capecitabine

Eligibility Criteria

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

You may qualify if:

• \) Histologic or cytologic diagnosis of breast cancer or colorectal cancer. Patients should have disease that is suitable for capecitabine monotherapy as defined by the NICE Guidelines.
• \) Patients must be within the first week of their first cycle of capecitabine treatment.
• \) Estimated life expectancy of greater than 3 months. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5) Total serum bilirubin less than or equal to 25 micromol/L. 6) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2.5 times the upper limit of the normal range.
• \) Serum albumin level greater than 32 g/L. 8) Creatinine clearance greater than or equal to 30 mL/minute. 9) Blood haemoglobin level of greater than 9 g/dL, with transfusion allowed. 10) Absolute neutrophil count greater than 2.5 x 109/L. 11) Platelet count greater than 100 x 109/L. 12) 18 years of age or older. 13) Written informed consent.

You may not qualify if:

• Pregnancy or breast feeding.
• Known HIV, Hepatitis B, or Hepatitis C infection.
• Known Gilbert syndrome.
• Uncontrolled diabetes (HbA1c greater than 7.5%).
• Any condition or disease that might affect oral absorption of medications, including:
• Crohn's disease
• Ulcerative colitis
• Major gastric or small bowel resection

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• University of Newcastle Upon-Tyne: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Frailty

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: March 14, 2018
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2019
• Last Updated: March 14, 2018

Record last verified: 2018-03