Condition category
Cancer
Date applied
15/06/2009
Date assigned
28/08/2009
Last edited
18/06/2015
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

NCT00854477

Protocol/serial number

CAP001

Study information

Scientific title

A pharmacokinetic study of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy for resection of pancreatic adenocarcinoma

Acronym

CAP001

Study hypothesis

1. To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy, 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
2. To ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery

Ethics approval

London, Northwick Park Hospital REC Committee, 07/08/2009, REC ref: 09/H0718/27

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

Pancreatic adenocarcinoma

Intervention

This is a clinical trial to evaluate the PK of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy. 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 previous studies using patients who have not undergone such surgery. 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 electrocardiogram (ECG), faecal elastase measurement and a serum or urine pregnancy test (for women of childbearing potential). Haematology and biochemistry (including CA19.9) will be repeated prior to each study drug administration.

All patients will receive 8 cycles of oral capecitabine chemotherapy at a dose of 1250 mg/m^2, administered twice daily at 12-hourly intervals for 14 consecutive days out of a 21-day cycle. Total proposed duration of therapy is 24 weeks, assuming patients commence all cycles without delay. Capecitabine and its metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during cycles 1 and 3 in all patients.

An optional pharmacogenetic blood sample will be collected prior to the start of chemotherapy treatment. Treatment should continue for 8 cycles unless there is evidence of disease progression, or unacceptable toxicity.

Intervention type

Drug

Phase

Phase I

Drug names

Capecitabine

Primary outcome measures

To establish the PK of capecitabine in patients who have undergone proximal pancreaticoduodenectomy, measured at week 7.

Secondary outcome measures

1. To establish the toxicity profile of capecitabine in these patients and to identify any dose limiting toxicities (DLT), measured at week 24
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

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Complete macroscopic resection for pathologically proven ductal adenocarcinoma (or poorly differentiated/undifferentiated carcinoma) of the pancreas (R0 or R1 resection)
2. Surgery must have included a proximal pancreatico-duodenectomy
3. Histological confirmation of the primary diagnosis and examination of all resection margins
4. At least 4 weeks since surgery, fully recovered from the operation and all surgical wounds fully healed
5. Aged greater than or equal to 18 years, either sex
6. World Health Organisation (WHO) performance status of less than or equal to 2
7. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient being registered on the study):
7.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl (patients may be transfused to this level, however, Hb must be above 9.0 g/dl before registration)
7.2. Neutrophils greater than or equal to 1.5 x 10^9/l
7.3. Platelets (Plts) greater than or equal to 100 x 10^9/l
7.4. Serum bilirubin less than or equal to 1.5 x upper normal limit (ULN)
7.5. 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)
7.6. 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
8. 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
9. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
10. Written, informed consent provided
11. Ability of the patient to co-operate with treatment and follow up must be ensured
12. 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 pancreatic lymphoma or other histological diagnosis
2. Macroscopically remaining tumour (R2 resection)
3. Evidence of malignant ascites, peritoneal or liver metastasis, or spread to other distant abdominal or extra-abdominal organs
4. History of confirmed ischaemic heart disease, concurrent congestive heart failure or prior history of class III/IV cardiac disease
5. Concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding malabsorption related directly to proximal pancreatic-duodenectomy)
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 which 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

06/12/2011

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