Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00032175
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GEMCAP
Study hypothesis
Does the addition of capecitabine to gemcitabine improve the survival or quality of life of patients with advanced pancreatic cancer?
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced Pancreatic Cancer
Intervention
Arm 1: Gemcitabine 1000 mg/m^2 weeks 1-7 followed by a 1-week rest. Treatment will then adopt a 28 day cycle where gemcitabine, 1000 mg/m^2, will be given once weekly for 3 weeks followed by a 1-week rest.
Arm 2: Treatment follows a 28 day cycle. Gemcitabine, 1000 mg/m^2, will be given weekly for 3 weeks followed by a 1-week rest. Capecitabine 830 mg/m^2 twice daily (total daily dose of 1660 mg/m^2) will be administered orally for 21 days followed by 7 days rest.
Intervention type
Drug
Phase
Phase III
Drug names
capecitabine, gemcitabine
Primary outcome measure
One-year survival.
Secondary outcome measures
1. Quality of life
2. Median and 2-year survival rates
3. Toxicity
4. Objective response rates
5. Assessment of pain
Overall trial start date
10/04/2002
Overall trial end date
18/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18 years
2. Histologically or cytologically proven ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
3. The presence of locally advanced or metastatic disease precluding curative surgical resection
4. Patients with macroscopic residual disease following resection confirmed by positive histology in post-resection tissue biopsies from the tumour bed (R2 resection) are also eligible
5. Unidimensionally measurable disease as assessed by computed tomography (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. The only exception will be for patients with an R2 resection who will be evaluated for survival only.
6. No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication
7. No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment
8. World Health Organisation (WHO) performance status 0, 1 or 2
9. Adequate bone marrow function with platelets >100 x 10^9/l; white blood cells (WBC) >3 x 10^9/l; neutrophils >1.5 x 10^9/l at the time of study entry
10. Serum bilirubin <35 µmol/l
11. Serum creatinine <180 µmol/l and calculated creatinine clearance over 50 ml/min
12. No concurrent uncontrolled medical condition
13. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
14. Life expectancy >3 months
15. Adequate contraceptive precautions if relevant
16. Informed written consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
508
Participant exclusion criteria
1. Medical or psychiatric conditions that compromise the patients ability to give informed consent
2. Intracerebral metastases or meningeal carcinomatosis
3. New York Heart Association classification Grade III or IV
4. Uncontrolled angina pectoris
5. Pregnancy or breast feeding
6. Impaired renal function with calculated creatinine clearance less than 50 ml/min
7. Previous investigational study drug
8. Known malabsorption syndromes
9. Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency
Recruitment start date
10/04/2002
Recruitment end date
18/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Sutton, Surrey
SM2 5PT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19858379
Publication citations
-
Results
Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP, Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer., J. Clin. Oncol., 2009, 27, 33, 5513-5518, doi: 10.1200/JCO.2009.24.2446.