Pharmacokinetic study of capecitabine after total gastrectomy for stomach adenocarcinoma

Not Applicable

• Conditions: Gastric adenocarcinoma; Cancer; Malignant neoplasm of stomach

• Registration Number: ISRCTN15898585
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-28
• Study Completion: 2013-11-30
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Histological confirmation of gastric carcinoma suitable for potentially curative resection
2. Surgery must be planned to involve a total gastrectomy
3. No concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding early satiety related to the presence of the malignancy)
4. Aged greater than or equal to 18 years, either sex
5. World Health Organisation (WHO) performance status of less than or equal to 2
6. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient going on study):
6.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl
6.2. Neutrophils greater than or equal to 1.5 x 10^9/l
6.3. Platelets (Plts) greater than or equal to 100 x 10^9/l
6.4. Serum bilirubin less than or equal to 1.5 x upper normal limit (ULN)
6.5. Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) less than or equal to 2.0 x ULN (if both are measured, both must be less than or equal to 2.0 x ULN)
6.6. Calculated creatinine clearance greater than or equal to 50 ml/min (uncorrected value) or isotope clearance measurement greater than or equal to 50 ml/min
7. 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
8. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
9. Written, informed consent provided
10. Ability of the patient to co-operate with treatment and follow up must be ensured
11. 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

1. Patients with gastric lymphoma or other histological diagnosis
2. Any evidence of malignant ascites, peritoneal or liver metastasis, spread to other distant abdominal or extra-abdominal organs
3. History of confirmed ischaemic heart disease, concurrent congestive heart failure or prior history of class III/IV cardiac disease
4. Concurrent mechanical or malabsorptive disorders precluding effective oral administration of the drug
5. Use of other concomitant chemotherapy
6. Pregnancy or lactation
7. Patients known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
8. Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection
9. Any other serious medical or psychological condition precluding adjuvant treatment
10. Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified