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Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

Primary Purpose

Adenocarcinoma of the Stomach

Status

Terminated

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

capecitabine

About this trial

This is an interventional basic science trial for Adenocarcinoma of the Stomach focused on measuring capecitabine, total gastrectomy, pharmacokinetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre
Edinburgh Cancer Centre, Western General Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00871273

First Posted

March 27, 2009

Last Updated

July 18, 2015

Sponsor

Cambridge University Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT00871273

Brief Title

Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Why Stopped

1. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Stomach

Keywords

capecitabine, total gastrectomy, pharmacokinetic

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

1 year

Title

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

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duncan Jodrell, DM MSc FRCP

Organizational Affiliation

Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cambridge

Country

United Kingdom

Facility Name

Edinburgh Cancer Centre, Western General Hospital

City

Edinburgh

Country

United Kingdom

12. IPD Sharing Statement

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Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

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