Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00871273|
Recruitment Status : Terminated (1. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study)
First Posted : March 30, 2009
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Stomach||Drug: capecitabine||Phase 4|
- To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2014|
- Drug: capecitabine
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 chemotherapyOther Name: Xeloda
- To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy. [ Time Frame: 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 ]
- 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. [ Time Frame: 1 year ]
- To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy. [ Time Frame: 1 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871273
|Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre|
|Cambridge, United Kingdom|
|Edinburgh Cancer Centre, Western General Hospital|
|Edinburgh, United Kingdom|
|Principal Investigator:||Duncan Jodrell, DM MSc FRCP||Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge|