NCT01099085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Feb 2009

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

April 4, 2010

Last Update Submit

February 15, 2017

Conditions

Gastric Cancer

Keywords

gastric cancer, unresectable/metastatic

Outcome Measures

Primary Outcomes (1)

  • Progression free survival of XP ± simvastatin

    1-year PFS

Study Arms (2)

XP/simvastatin

ACTIVE COMPARATOR

Capecitabine/cisplatin + simvastatin

Drug: Simvastatin

XP/placebo

PLACEBO COMPARATOR

Capecitabine/cisplatin + placebo

Drug: Placebo

Interventions

SimvastatinDRUG

simvastatin 40 mg qd daily

XP/simvastatin
PlaceboDRUG

Placebo

XP/placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Cancer Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25218337DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2010

First Posted

April 6, 2010

Study Start

February 1, 2009

Primary Completion

June 1, 2013

Study Completion

January 1, 2015

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

KR(1)