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Trial record 89 of 435 for:    colon cancer AND Capecitabine

Association of Capecitabine Pharmacokinetics and Toxicity With Aging

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ClinicalTrials.gov Identifier: NCT03465202
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Drug: Capecitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine Drug: Capecitabine
Other Name: Xeloda




Primary Outcome Measures :
  1. Area under the curve (AUC) of capecitabine and metabolites [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose ]
    Measurement of AUC of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.


Secondary Outcome Measures :
  1. Toxicities and grades as scaled by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03 [ Time Frame: Six months ]
    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.

  2. Progression free survival as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: From time of enrollment until first documented progression ]
    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)'

  3. Response as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: From time of enrollment to first documented response ]

    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.'


  4. Grip strength measured in kg [ Time Frame: During 6-hour pharmacokinetic study session ]
    Grip strength measured in kg by the grip strength test (using the Takei handheld dynamometer)

  5. Frailty as measured by the Edmonton Frail Scale [ Time Frame: During 6-hour pharmacokinetic study session ]
    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.

  6. Nutritional status as measured by the Mini Nutritional Assessment questionnaire [ Time Frame: During 6-hour pharmacokinetic study session ]

    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.


  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 [ Time Frame: During 6-hour pharmacokinetic study session ]
    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'.

  8. Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay) [ Time Frame: 0 hours post dose (pre-dose) ]
    Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay).

  9. Maximum plasma concentration (Cmax) of capecitabine and metabolites [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose ]
    Cmax of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.

  10. Time of maximum plasma concentration (Tmax) of capecitabine and metabolites [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose ]
    Cmax of capecitabine and its metabolites 5'deoxy-5-fluorocytidine (5'DFCR), 5'deoxy-5-fluorouridine (5'DFUR), and 5-fluorouracil.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Pregnancy or breast feeding.
  2. Known HIV, Hepatitis B, or Hepatitis C infection.
  3. Known Gilbert syndrome.
  4. Uncontrolled diabetes (HbA1c greater than 7.5%).
  5. Any condition or disease that might affect oral absorption of medications, including:

    1. Crohn's disease
    2. Ulcerative colitis
    3. Major gastric or small bowel resection

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03465202     History of Changes
Other Study ID Numbers: SBRU201501
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Capecitabine
Pharmacokinetics
Ageing
Frailty
Breast cancer
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents