Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

• Status: Unknown status
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC. The investigators have designed a randomized, controlled and open. Advanced stage was considered for patients with T4 or N1 or M1 according to the TNM classification. It has been estimated sample size per treatment arm of 73 patients (146 patients in total). Randomization was done on a stratified by location (CE or CG). All patients receive hatitual treatment (surgery and / or chemotherapy and / or radiotherapy and / or palliative) for each of their clinical conditions. The experimental group will receive one tablet of 40 mg of pravastatin orally every 24 hours (breakfast) for 2 years. There will be a monthly monitoring of these patients for at least 2 years which includes an analytics. Every 2 months there will be an abdominal-pelvic CT scan to assess progression and treatment response.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Donostia
• Treatments: Pravastatin

Criteria

Inclusion Criteria:

• Over 18 years,

• Esophageal or gastric cancer histologically confirmed (squamous or adenocarcinoma) for the first time,

• Advanced stage (T4 or N1 or M1) according to the fourth edition of TNM classification,

• Signing the informed consent.

Exclusion Criteria:

• Patients who routinely take (more than 3 days a week) anti-inflammatory drugs or aspirin,

• Patients receiving oral anticoagulants, fibrates, cyclosporine and oral contraceptives,

• Patients with hypersensitivity to pravastatin,

• Pregnant or lactating women,

• Peripheral neuropathy grade 2 or greater,

• Patients who have been diagnosed in the previous 5 years other than skin cancer tumor that is not melanoma or carcinoma in situ of cervix or bladder,

• Patients receiving chemotherapy or radiotherapy for another type of tumor,

• Patients in their laboratory parameters before starting the present study transaminases or alkaline phosphatase more than twice the normal value,

• Patients with platelet count less than 100.000/mm3, absolute neutrophil count below 1000/mm3,

• Patients with evidence of bleeding diathesis or coagulopathy,

• Patients with heart failure than NYHA grade II,

• Patients with creatinine greater than 2 mg / dL,

• Patients over 75 years,

• Asthmatics,

• Patients with physical or mental disability,

• Patients with alcoholism, OR

• Patients with hereditary muscle disease.