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Association of Capecitabine Pharmacokinetics and Toxicity With Aging

7. mars 2018 oppdatert av: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Fase 4

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

      -

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Capecitabin
Legemiddel: Capecitabin
Andre navn:
  • Xeloda

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area under the curve (AUC) of capecitabine and metabolites
Tidsramme: 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.
0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Toxicities and grades as scaled by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
Tidsramme: 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.
Six months
Progression free survival as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Tidsramme: 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)'
From time of enrollment until first documented progression
Response as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Tidsramme: 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.'
From time of enrollment to first documented response
Grip strength measured in kg
Tidsramme: During 6-hour pharmacokinetic study session
Grip strength measured in kg by the grip strength test (using the Takei handheld dynamometer)
During 6-hour pharmacokinetic study session
Frailty as measured by the Edmonton Frail Scale
Tidsramme: 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.
During 6-hour pharmacokinetic study session
Nutritional status as measured by the Mini Nutritional Assessment questionnaire
Tidsramme: 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.
During 6-hour pharmacokinetic study session
Quality of life as assessed by the European Organization for Research and Treatment of Cancer quality of life (EORTC-QLQ-C30 version 3) questionnaire
Tidsramme: 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'.
During 6-hour pharmacokinetic study session
Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay)
Tidsramme: 0 hours post dose (pre-dose)
Plasma cytidine deaminase activity (measured in units/mg protein by spectrophotometric assay).
0 hours post dose (pre-dose)
Maximum plasma concentration (Cmax) of capecitabine and metabolites
Tidsramme: 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.
0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose
Time of maximum plasma concentration (Tmax) of capecitabine and metabolites
Tidsramme: 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.
0 (pre-dose), 0.5, 1, 2, 4, and 6 hours post dose

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Samarbeidspartnere

University of Newcastle Upon-Tyne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2016

Primær fullføring (Forventet)

1. mai 2018

Studiet fullført (Forventet)

1. november 2019

Datoer for studieregistrering

Først innsendt

7. august 2015

Først innsendt som oppfylte QC-kriteriene

7. mars 2018

Først lagt ut (Faktiske)

14. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SBRU201501

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