- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03465202
Association of Capecitabine Pharmacokinetics and Toxicity With Aging
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
Přehled studie
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 4
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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:
- 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
-
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Kapecitabin
|
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Area under the curve (AUC) of capecitabine and metabolites
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Toxicities and grades as scaled by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Molekulární mechanismy farmakologického působení
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Kapecitabin
Další identifikační čísla studie
- SBRU201501
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