Adenocarcinoma of the StomachPhase 4NCT00871273
Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma
A Phase 4 study testing capecitabine in people with Adenocarcinoma of the Stomach, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Stomach
- What is being tested?
- capecitabine
- Type of treatment
- Pill or oral medicine
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2009to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre
Cambridge
Edinburgh Cancer Centre, Western General Hospital
Edinburgh
About this study
Official title: A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach
The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Read the 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.
- Conditions
- Adenocarcinoma of the Stomach
- Being tested
- capecitabine
- Keywords
- capecitabine, total gastrectomy, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Measured: 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.
Measured: 1 year
To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2013
- Study completionOct 2014
Why it stopped: 1\. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duncan Jodrell, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Duncan Jodrell, DM MSc FRCP, Principal investigator, Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871273
- Sponsor's protocol ID
- CAP002
- Status last verified
- Jul 2015
- First submitted
- 27 Mar 2009
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach
- ClinicalTrials.gov ID
- NCT00871273
- Acronym / sponsor ID
- CAP002
- Conditions
- Adenocarcinoma of the Stomach
- Keywords
- capecitabine, total gastrectomy, pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1\. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabineAlso: Xelodafilm-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 | Drug | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 1\. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duncan Jodrell, DM MSc FRCP principal investigator
Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing capecitabine in people with Adenocarcinoma of the Stomach, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 1\. Slow recruitment; 2. Change to clinical environment reducing the pool of potentially eligible patients; 3. Availability of data from another similar study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.