Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S. Sleijfer

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Erasmus Medical Center, Department of Medical Oncology (Netherlands)

Sponsor details

P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes