Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Simvastatin; Drug: Placebo

• Registration Number: NCT01099085
• Lead Sponsor: Samsung Medical Center

Brief Summary

Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-04-04
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Primary Completion: 2013-06
• Study Completion: 2015-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XP/simvastatin	Simvastatin	Capecitabine/cisplatin + simvastatin
XP/placebo	Placebo	Capecitabine/cisplatin + placebo

Primary Outcome Measures

Name	Time	Method
Progression free survival of XP ± simvastatin	1-year PFS

Trial Locations

Locations (1)

Samsung Cancer Center; 🇰🇷 Seoul, Korea, Republic of