Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
NCT ID: NCT01099085
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2009-02-28
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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XP/simvastatin
Capecitabine/cisplatin + simvastatin
Simvastatin
simvastatin 40 mg qd daily
XP/placebo
Capecitabine/cisplatin + placebo
Placebo
Placebo
Interventions
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Simvastatin
simvastatin 40 mg qd daily
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. measurable or evaluable disease according to RECIST
4. age, 18 years or older
5. ECOG performance status 0 - 2
6. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 3.0 mg/dL
7. signed written informed consent
Exclusion Criteria
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. active and uncontrollable bleeding from gastrointestinal tract
5. known history of hypersensitivity to study drugs
6. patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Ki Kang
Professor
Locations
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Samsung Cancer Center
Seoul, , South Korea
Countries
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References
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Kim ST, Kang JH, Lee J, Park SH, Park JO, Park YS, Lim HY, Hwang IG, Lee SC, Park KW, Lee HR, Kang WK. Simvastatin plus capecitabine-cisplatin versus placebo plus capecitabine-cisplatin in patients with previously untreated advanced gastric cancer: a double-blind randomised phase 3 study. Eur J Cancer. 2014 Nov;50(16):2822-30. doi: 10.1016/j.ejca.2014.08.005. Epub 2014 Sep 15.
Other Identifiers
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2008-12-019
Identifier Type: -
Identifier Source: org_study_id
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