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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27982
Enrollment
43
Registered
2005-09-20
Start date
2005-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced irresectable or metastatic gastric carcinoma

Interventions

Control arm (ECC): epirubicin 50 mg/m2 i.v., day 1, Cisplatin 60 mg/m2 i.v., day 1, 3-hour infusion, Capecitabine 1000 mg/m2 in the morning and 1000 mg/m2 in the evening, p.o., day 1-14. ECC will be g

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven, irresectable gastric adenocarcinoma, except carcinoma of the cardia, WHO 0-2, ability to swallow, adequate hepatic, renal and bone marrow function.

Exclusion criteria

Exclusion criteria: Prior chemotherapy or radiotherapy, current treatment with HMG-CoA-reductase inhibitor, peripheral neurotoxicity grade >2.

Design outcomes

Primary

MeasureTime frame
Progression free survival rate (PFR) after 6 months.—

Secondary

MeasureTime frame
Response rate scored according to the RECIST criteria, overall survival, quality of life, and toxicity graded according the international “Common Toxicity Criteria”.—

Contacts

Public ContactS. Sleijfer

Department of Oncology, Erasmus MC Cancer institute, room He 116

s.sleijfer@erasmusmc.nl+31 10 7034447

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)