A randomized phase II trial comparing epirubicin, cisplatin, and capecitabine versus the combination of epirubicin, cisplatin, and capecitabine with pravastatin in patients with irresectable or metastatic gastric carcinoma

ISRCTN ISRCTN23062732
DOI https://doi.org/10.1186/ISRCTN23062732
Secondary identifying numbers NTR416; EMC 04-147
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
06/07/2009
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

Not provided at time of registration

Contact information

Dr S. Sleijfer
Scientific

Erasmus MC - Daniel den Hoed
Department of Medical Oncology
Groene Hilledijk 301
Rotterdam
3075 EA
Netherlands

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymECC
Study objectivesTreatment 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedGastric carcinoma
InterventionControl 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)capecitabine, epirubicin, cisplatin, pravastatin
Primary outcome measureProgression free survival rate (PFR) after 6 months.
Secondary outcome measures1. 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 study start date01/02/2005
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants43
Key inclusion criteria1. 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
Key exclusion criteria1. Prior chemotherapy or radiotherapy
2. Current treatment with HMG-CoA-reductase inhibitor
3. Peripheral neurotoxicity grade >2
Date of first enrolment01/02/2005
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands

Sponsor information

Erasmus Medical Center, Department of Medical Oncology (Netherlands)
Hospital/treatment centre

P.O. Box 5201
Rotterdam
3008 AE
Netherlands

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Center (Netherlands)
Government organisation / Universities (academic only)
Alternative name(s)
Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan