Back to resultsTrial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, unresectable/metastatic
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
- 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
- measurable or evaluable disease according to RECIST
- age, 18 years or older
- ECOG performance status 0 - 2
- 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
- signed written informed consent
Exclusion Criteria:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- active and uncontrollable bleeding from gastrointestinal tract
- known history of hypersensitivity to study drugs
- 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)
Sites / Locations
- Samsung Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
XP/simvastatin
XP/placebo
Arm Description
Capecitabine/cisplatin + simvastatin
Capecitabine/cisplatin + placebo
Outcomes
Primary Outcome Measures
Progression free survival of XP ± simvastatin
Secondary Outcome Measures
Full Information
NCT ID
NCT01099085
First Posted
April 4, 2010
Last Updated
February 15, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01099085
Brief Title
Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Official Title
Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, unresectable/metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XP/simvastatin
Arm Type
Active Comparator
Arm Description
Capecitabine/cisplatin + simvastatin
Arm Title
XP/placebo
Arm Type
Placebo Comparator
Arm Description
Capecitabine/cisplatin + placebo
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
simvastatin 40 mg qd daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression free survival of XP ± simvastatin
Time Frame
1-year PFS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
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
measurable or evaluable disease according to RECIST
age, 18 years or older
ECOG performance status 0 - 2
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
signed written informed consent
Exclusion Criteria:
severe co-morbid illness and/or active infections
pregnant or lactating women
active CNS metastases not controllable with radiotherapy or corticosteroids
active and uncontrollable bleeding from gastrointestinal tract
known history of hypersensitivity to study drugs
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)
Facility Information:
Facility Name
Samsung Cancer Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25218337
Citation
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.
Results Reference
derived
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Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
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