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Breast CancerPhase 4NCT03465202

Association of Capecitabine Pharmacokinetics and Toxicity With Aging

A Phase 4 study testing Capecitabine in people with Breast Cancer and Colorectal Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Colorectal Cancer
What is being tested?
Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
May 2016to Nov 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) 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.
  • 2) Patients must be within the first week of their first cycle of capecitabine treatment.
  • 3) 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.
  • 7) 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Ulcerative colitis
  • Major gastric or small bowel resection
  • -

About this study

Official title: A Prospective Evaluation of Capecitabine and Metabolite Pharmacokinetics in Elderly Breast and Colorectal Cancer Patients and Their Association With Toxicity and Molecular Markers of Enzyme Activity and Aging

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.

Being tested
Capecitabine
Keywords
Capecitabine, Pharmacokinetics, Ageing, Frailty, Breast cancer, Colorectal cancer
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03465202
Study groupRoleWhat they receive
CapecitabineExperimentalNot described
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

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

    Toxicity grade(s) as measured by CTCAE version 4.03 (published by the U.S. Department of Heath and Human Services 2009). General grading scheme is as follows: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

    Measured: Six months

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

    Progression free survival as measured by the RECIST criteria version 1.1 (Eisenhauer et al., 2009). The RECIST criteria define progression as 'at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression)'

    Measured: From time of enrollment until first documented progression

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

    Complete or partial response as measured by the RECIST criteria version 1.1. (Eisenhauer et al., 2009) Complete response = 'Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial response = 'At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'

    Measured: From time of enrollment to first documented response

  4. Grip strength measured in kg

    Grip strength measured in kg by the grip strength test (using the Takei handheld dynamometer)

    Measured: During 6-hour pharmacokinetic study session

  5. Frailty as measured by the Edmonton Frail Scale

    Frailty as measured by the Edmonton Frail Scale. A 17 point scale that measures 9 frailty domains. 0-5: not frail; 6-7: vulnerable; 8-9: mild frailty; 10-11: moderate frailty; 12-17: severe frailty.

    Measured: During 6-hour pharmacokinetic study session

  6. Nutritional status as measured by the Mini Nutritional Assessment questionnaire

    Nutritional status as measured by the Mini Nutritional Assessment questionnaire, a 30 point test on nutritional status. Scoring: 24 to 30 points: Normal nutritional status.

    17 to 23.5 points: At risk of malnutrition. Less than 17 points: malnourished.

    Measured: During 6-hour pharmacokinetic study session

  7. Quality of life as assessed by the European Organization for Research and Treatment of Cancer quality of life (EORTC-QLQ-C30 version 3) questionnaire

    Quality of life as measured by the EORTC-QLQ-C30 version 3 questionnaire. This questionnaire assesses the quality of life of cancer patients in a series of 30 questions, with 28 of the questions on a scale of 1 to 4 where 1 is 'not at all' and 4 is 'very much'. Final two questions relate to overall quality of life and health on a scale of 1 to 7, where 1 is 'very poor' and 7 is 'excellent'.

    Measured: During 6-hour pharmacokinetic study session

  8. Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay)

    Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay).

    Measured: 0 hours post dose (pre-dose)

  9. Maximum plasma concentration (Cmax) of capecitabine and metabolites

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

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

  10. Time of maximum plasma concentration (Tmax) of capecitabine and metabolites

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2018
  2. Study startMay 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03465202
Sponsor's protocol ID
SBRU201501
Status last verified
Mar 2018
First submitted
7 Aug 2015
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Capecitabine in people with Breast Cancer and Colorectal Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (AUC) of capecitabine and metabolites (time frame: 0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03465202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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