Condition category
Cancer
Date applied
15/06/2009
Date assigned
28/08/2009
Last edited
20/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Duncan Jodrell

ORCID ID

Contact details

Oncology Centre
Box 193
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00871273

Protocol/serial number

CAP002

Study information

Scientific title

A pharmacokinetic study of capecitabine in patients undergoing peri-operative chemotherapy and a total gastrectomy for adenocarcinoma of the stomach

Acronym

CAP002

Study hypothesis

To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy, i.e. the action of drug capecitabine in the body over a period of time, including the processes of absorption, distribution, localisation in tissues, biotransformation and excretion.

Ethics approval

Sunderland Research Ethics Committee, 16/06/2009, ref: 09/H0904/38

Study design

Multicentre non-randomised single-arm open-label study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gastric adenocarcinoma

Intervention

This is a clinical trial to evaluate the PK of adjuvant capecitabine in patients who have undergone a total gastrectomy. The study will compare the pharmacokinetic profile of capecitabine administered to patients with gastric cancer pre- and post-gastrectomy (using patients as their own controls) and also compare the data accrued with historical data for capecitabine PK. The aim is to ensure equivalent capecitabine exposure following total gastrectomy.

Screening tests will consist of demographic details, complete medical history, physical exam, vital signs, haematology and biochemistry tests. Electrocardiogram (ECG), tumour measurement (computed tomography [CT] abdomen, chest X-ray or CT chest) and a serum or urine pregnancy test (for women of childbearing potential) will also be performed. Haematology and biochemistry will be repeated prior to each study drug administration.

All patients will receive ECX chemotherapy which includes epirubicin 50 mg/m^2 (intravenous [iv] bolus) on day 1, cisplatin 60 mg/m^2 (iv infusion) on day 1 and oral capecitabine chemotherapy at a dose of 625 mg/m^2 administered twice daily at 12 hourly intervals for 21 consecutive days out of a 21-day cycle.

Capecitabine and its metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during cycles 1 and 4 in all patients, using a validated HPLC-MS method. An optional pharmacogenetic sample will be collected prior to the start of chemotherapy treatment. Treatment will continue for 3 cycles pre-operatively and 3 cycles post-operatively unless there is evidence of disease progression on chemotherapy, unacceptable toxicity or treatment is discontinued at the patient's request.

Intervention type

Drug

Phase

Not Applicable

Drug names

Capecitabine

Primary outcome measures

To establish the PK of capecitabine in patients who have undergone a total gastrectomy, measured at week 18 +/- 2

Secondary outcome measures

1. To compare the PK 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
2. To ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery

Measured at PK analysis.

Overall trial start date

01/08/2009

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological confirmation of gastric carcinoma suitable for potentially curative resection
2. Surgery must be planned to involve a total gastrectomy
3. No concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding early satiety related to the presence of the malignancy)
4. Aged greater than or equal to 18 years, either sex
5. World Health Organisation (WHO) performance status of less than or equal to 2
6. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient going on study):
6.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl
6.2. Neutrophils greater than or equal to 1.5 x 10^9/l
6.3. Platelets (Plts) greater than or equal to 100 x 10^9/l
6.4. Serum bilirubin less than or equal to 1.5 x upper normal limit (ULN)
6.5. Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) less than or equal to 2.0 x ULN (if both are measured, both must be less than or equal to 2.0 x ULN)
6.6. Calculated creatinine clearance greater than or equal to 50 ml/min (uncorrected value) or isotope clearance measurement greater than or equal to 50 ml/min
7. Female patients of child-bearing potential must have a negative serum or urine pregnancy test within two weeks 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
8. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
9. Written, informed consent provided
10. Ability of the patient to co-operate with treatment and follow up must be ensured
11. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Patients with gastric lymphoma or other histological diagnosis
2. Any evidence of malignant ascites, peritoneal or liver metastasis, spread to other distant abdominal or extra-abdominal organs
3. History of confirmed ischaemic heart disease, concurrent congestive heart failure or prior history of class III/IV cardiac disease
4. Concurrent mechanical or malabsorptive disorders precluding effective oral administration of the drug
5. Use of other concomitant chemotherapy
6. Pregnancy or lactation
7. Patients known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
8. Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection
9. Any other serious medical or psychological condition precluding adjuvant treatment
10. Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial

Recruitment start date

01/11/2009

Recruitment end date

30/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oncology Centre
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

R&D Department
Box 146
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Industry

Funder name

Roche (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes