Pharmacokinetic study of adjuvant capecitabine after resection of pancreatic adenocarcinoma

ISRCTN	ISRCTN88098646
DOI	https://doi.org/10.1186/ISRCTN88098646
ClinicalTrials.gov number	NCT00854477
Secondary identifying numbers	CAP001

Submission date: 15/06/2009
Registration date: 28/08/2009
Last edited: 20/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-study-looking-capecitabine-after-surgery-for-cancer-pancreas-cap-001

Contact information

Prof Duncan Jodrell
Scientific

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

Study information

Study design	Multicentre non-randomised single-arm open-label study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A pharmacokinetic study of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy for resection of pancreatic adenocarcinoma
Study acronym	CAP001
Study objectives	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(s)	London, Northwick Park Hospital REC Committee, 07/08/2009, REC ref: 09/H0718/27
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Capecitabine
Primary outcome measure	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 study start date	01/08/2009
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	12
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	06/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oncology Centre

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Industry

Roche (UK)
Government organisation / For-profit companies (industry)

Alternative name(s): F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location: Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

20/03/2019: No publications found, verifying study status with principal investigator.
15/11/2017: No publications found, verifying study status with principal investigator.