Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma | Stopped
Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma
Health Conditions
  • Adenocarcinoma of the Stomach
Stopped
Recruitment Status
NCT00871273
Primary Trial ID Number
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Primary Outcome Measures
  • To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.; Samples collected predose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, and 24 hours on day 1 of cycles 1 and 4
Secondary Outcome Measures
  • To compare the pharmacokinetic profile of capecitabine administered to patients with gastric cancer pre- and post-gastrectomy and to compare this to historical data of capecitabine PK values in patients with other cancer types.; 1 year; To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy.; 1 Year
Research Question
  • The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Patients must have histologically confirmed gastric carcinoma suitable for
  • potentially curative resection.
  • - Surgery must be planned to involve a total gastrectomy.
  • - No concurrent mechanical or malabsorptive disorders precluding affective oral
  • administration of the drug (excluding early satiety related to the presence of the
  • malignancy).
  • - Age ≥ 18 years.
  • - World Health Organisation (WHO) performance status of ≤ 2 (Appendix 1).
  • - Haematological and biochemical indices (These measurements must be performed within
  • one week prior to the patient going on study.)
  • - Haemoglobin (Hb) ≥ 9.0 g/dl
  • - Neutrophils ≥ 1.5 x 109/L
  • - Platelets (Plts) ≥ 100 x 109/L
  • - Serum bilirubin ≤ 1.5 x upper normal limit
  • - Alanine amino-transferase (ALT) and / or aspartate amino-transferase (AST) ≤ 2.0 x
  • upper limit of normal (ULN). (If both are measured, both must be ≤ 2.0 x ULN)
  • - Calculated creatinine clearance ≥ 50 ml/min (uncorrected value) or isotope clearance
  • measurement ≥ 50ml/min
  • - Female patients of child-bearing potential must have a negative serum or urine
  • pregnancy test prior to enrolment and agree to use appropriate medically approved
  • contraception for four weeks prior to entering the trial, during the trial, and for
  • six months afterwards.
  • - Male patients must agree to use appropriate medically approved contraception during
  • the trial and for six months afterwards.
  • - Written, informed consent provided.
  • - Ability of the patient to co-operate with treatment and follow up must be ensured.
  • - Patients receiving oral anti-coagulation prior to entry into the study, must be
  • converted to low molecular weight heparin in light of the interaction between
  • capecitabine and warfarin.
  • Exclusion Criteria:
  • - Patients with gastric lymphoma or other histological diagnosis
  • - Any evidence of malignant ascites, peritoneal or liver metastasis, spread to other
  • distant abdominal or extra-abdominal organs.
  • - History of confirmed Ischaemic Heart Disease, concurrent congestive heart failure or
  • prior history of class III / IV cardiac disease (Appendix 2 - New York Heart
  • Association (NYHA) Scale)
  • - Concurrent mechanical or malabsorptive disorders precluding effective oral
  • administration of the drug
  • - Use of other concomitant chemotherapy
  • - Pregnancy or Lactation
  • - Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human
  • Immunodeficiency Virus (HIV).
  • - Patients who are high medical risks because of non-malignant systemic disease
  • including active uncontrolled infection.
  • - Any other serious medical or psychological condition precluding adjuvant treatment
  • - Patients with any other condition which in the Investigator's opinion would not make
  • the patient a good candidate for the clinical trial.
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - Patients must have histologically confirmed gastric carcinoma suitable for
  • potentially curative resection.
  • - Surgery must be planned to involve a total gastrectomy.
  • - No concurrent mechanical or malabsorptive disorders precluding affective oral
  • administration of the drug (excluding early satiety related to the presence of the
  • malignancy).
  • - Age ≥ 18 years.
  • - World Health Organisation (WHO) performance status of ≤ 2 (Appendix 1).
  • - Haematological and biochemical indices (These measurements must be performed within
  • one week prior to the patient going on study.)
  • - Haemoglobin (Hb) ≥ 9.0 g/dl
  • - Neutrophils ≥ 1.5 x 109/L
  • - Platelets (Plts) ≥ 100 x 109/L
  • - Serum bilirubin ≤ 1.5 x upper normal limit
  • - Alanine amino-transferase (ALT) and / or aspartate amino-transferase (AST) ≤ 2.0 x
  • upper limit of normal (ULN). (If both are measured, both must be ≤ 2.0 x ULN)
  • - Calculated creatinine clearance ≥ 50 ml/min (uncorrected value) or isotope clearance
  • measurement ≥ 50ml/min
  • - Female patients of child-bearing potential must have a negative serum or urine
  • pregnancy test prior to enrolment and agree to use appropriate medically approved
  • contraception for four weeks prior to entering the trial, during the trial, and for
  • six months afterwards.
  • - Male patients must agree to use appropriate medically approved contraception during
  • the trial and for six months afterwards.
  • - Written, informed consent provided.
  • - Ability of the patient to co-operate with treatment and follow up must be ensured.
  • - Patients receiving oral anti-coagulation prior to entry into the study, must be
  • converted to low molecular weight heparin in light of the interaction between
  • capecitabine and warfarin.
  • Exclusion Criteria:
  • - Patients with gastric lymphoma or other histological diagnosis
  • - Any evidence of malignant ascites, peritoneal or liver metastasis, spread to other
  • distant abdominal or extra-abdominal organs.
  • - History of confirmed Ischaemic Heart Disease, concurrent congestive heart failure or
  • prior history of class III / IV cardiac disease (Appendix 2 - New York Heart
  • Association (NYHA) Scale)
  • - Concurrent mechanical or malabsorptive disorders precluding effective oral
  • administration of the drug
  • - Use of other concomitant chemotherapy
  • - Pregnancy or Lactation
  • - Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human
  • Immunodeficiency Virus (HIV).
  • - Patients who are high medical risks because of non-malignant systemic disease
  • including active uncontrolled infection.
  • - Any other serious medical or psychological condition precluding adjuvant treatment
  • - Patients with any other condition which in the Investigator's opinion would not make
  • the patient a good candidate for the clinical trial.
Interventions
Drug; capecitabine; film-coated tablet 1250 mg/m2 twice daily 14 days for 14 days. Number of cycles: 3 cycles pre-operatively and 3 cycles post-operatively unless there is evidence of disease progression on chemotherapy; []
Design Details
Sorry, this information is not available
Study Design
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Results Reporting
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Acronym
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Scientific Title
A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach
Secondary Trial Identifying Number
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Website
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Study Funded By
Cambridge University Hospitals NHS Foundation Trust
Funder Type
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Study Sponsored By
Cambridge University Hospitals NHS Foundation Trust
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

27 Mar 2009

Last Updated

18 Jul 2015

Date Record Refreshed on UKCTG

24 Jul 2015