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 |
| Protocol serial number | NTR416; EMC 04-147 |
| Sponsor | Erasmus Medical Center, Department of Medical Oncology (Netherlands) |
| Funder | Erasmus Medical Center (Netherlands) |
- 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
Scientific
Erasmus MC - Daniel den Hoed
Department of Medical Oncology
Groene Hilledijk 301
Rotterdam
3075 EA
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ECC |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | capecitabine, epirubicin, cisplatin, pravastatin |
| Primary outcome measure(s) |
Progression free survival rate (PFR) after 6 months. |
| Key secondary outcome measure(s) |
1. Response rate scored according to the RECIST criteria |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 43 |
| Key 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 |
| Key exclusion criteria | 1. Prior chemotherapy or radiotherapy 2. Current treatment with HMG-CoA-reductase inhibitor 3. Peripheral neurotoxicity grade >2 |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands
3075 EA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
