Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments simvastatin, placebo
Phase phase 3
Sponsor Samsung Medical Center
Start date February 2009
End date June 2013
Trial size 244 participants
Trial identifier NCT01099085, 2008-12-019

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Capecitabine/cisplatin + simvastatin
simvastatin
simvastatin 40 mg qd daily
(Placebo Comparator)
Capecitabine/cisplatin + placebo
placebo
Placebo

Primary Outcomes

Measure
Progression free survival of XP ± simvastatin
time frame: 1-year PFS

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Samsung Medical Center.