Patients undergoing peri-operative chemotherapy and a total gastrectomy for adenocarcinoma of the stomach
Conditions
Interventions
Trade Name: Capecitabine
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
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. • 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 (Patients may be transfused to this level, however, HB must be above 9.0 before registration) - Neutrophils = 1.5 x 10^9/L - Platelets (Plts) = 100 x 10^9/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 = 50 mL/min • Female patients of child-bearing potential must have a negative serum or urine pregnancy test within two weeks 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.; Secondary Objective: To compare the PK 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. To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy. ;Primary end point(s): This is a PK sampling study, therefore there are no specific endpoints | — |
Countries
United Kingdom
Outcome results
None listed