Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

Adenocarcinoma of the Stomach Clinical Trial

Official title: A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

Primary Objective:

• To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy

Secondary Objectives:

• 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.

• To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy.

This is a clinical trial to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy. The study also aims to establish the toxicity profile of capecitabine in these patients, to identify any dose limiting toxicities (DLT), and to ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy. Screening tests will consist of demographic details, complete medical history, physical exam, vital signs, tumour serum markers, haematology and biochemistry tests. There will also be an ECG, chest X-Ray or CT thorax, CT abdomen and a serum or urine pregnancy test (for women of childbearing potential). Haematology and Biochemistry will be repeated prior to each study drug administration. All patients will receive 6 cycles of oral capecitabine chemotherapy at a dose of 625 mg/m2, administered twice daily at 12 hourly intervals for 21 consecutive days. Total proposed duration of therapy is 3 cycles pre-operatively and 3 cycles post-operatively. Capecitabine and its metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 4th cycles in all patients. Treatment should continue for 6 cycles unless there is evidence of disease progression, or unacceptable toxicity. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Stomach

• NCT number: NCT00871273
• Study type: Interventional
• Source: Cambridge University Hospitals NHS Foundation Trust
• Status: Terminated
• Phase: Phase 4
• Start date: November 2009
• Completion date: October 2014