Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

NCT00871273 | Terminated Phase 4

• 1 other identifier: CAP002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Adenocarcinoma of the Stomach

Keywords

capecitabine; total gastrectomy; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

capecitabine DRUG

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

Also known as: Xeloda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (2)

Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre

Cambridge, United Kingdom

Location

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, United Kingdom

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Duncan Jodrell, DM MSc FRCP

  Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Duncan Jodrell

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

GB (2)