Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Capecitabine

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.