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Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Phase 3
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Inclusion Criteria:

1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or
gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the

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:

1. severe co-morbid illness and/or active infections

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival of XP ± simvastatin

Outcome Time Frame:

1-year PFS

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

January 2014

Related Keywords:

  • Gastric Cancer
  • gastric cancer, unresectable/metastatic
  • Stomach Neoplasms