Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR416; EMC 04-147
Study information
Scientific title
Acronym
ECC
Study hypothesis
Treatment with capecitabine, combined with epirubicin and cisplatin (ECC) has been proven to improve time to progression and survival in patients with advanced, non-resectable gastric cancer. HMG-CoA-reductase inhibitors have anti-tumor activity in vitro against gastric carcinoma. Statins furthermore interact synergistically with cisplatin, 5-FU and doxorubicin both in vitro and animal models. As prognosis of advanced irresectable gastric cancer is poor, it is worthwhile to study whether the combination of ECC and pravastatin is an option for these patients.
Ethics approval
Received from local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gastric carcinoma
Intervention
Control arm (ECC): epirubicin 50 mg/m2 iv, day 1, Cisplatin 60 mg/m2 iv, day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, po, day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles.
Experimental arm (ECC plus pravastatin): Epirubicin 50 mg/m2 iv, day 1, Cisplatin 60 mg/m2 iv, day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, po, day 1-14. ECC will be given at 3-week intervals, for a maximum total of 6 cycles. In addition, patients will receive daily 40 mg pravastatin, from day 1 to 1 week after the capecitabine of the last ECC.
Intervention type
Drug
Phase
Phase II
Drug names
capecitabine, epirubicin, cisplatin, pravastatin
Primary outcome measures
Progression free survival rate (PFR) after 6 months.
Secondary outcome measures
1. Response rate scored according to the RECIST criteria
2. Overall survival
3. Quality of life
4. Toxicity graded according the international 'Common Toxicity Criteria'
Overall trial start date
01/02/2005
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven, irresectable gastric adenocarcinoma, except carcinoma of the cardia
2. WHO 0-2
3. Ability to swallow
4. Adequate hepatic, renal and bone marrow function
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
43
Participant exclusion criteria
1. Prior chemotherapy or radiotherapy
2. Current treatment with HMG-CoA-reductase inhibitor
3. Peripheral neurotoxicity grade >2
Recruitment start date
01/02/2005
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Center (Netherlands)
Alternative name(s)
Erasmus Medical Center, Erasmus MC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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