None listed
Conditions
Interventions
Group 1 Type of group
300 mg of vorinostat orally twice a day (2 v / d), in the morning and at night, for 3 consecutive days every 7 days (3 days of treatment and 4 days of rest). This scheme will be repeated every week in such a way that 21 days form a treatment cycle. Each treatment cycle will include 9 days of treatment.
Group name:Group 2 Type of group
A placebo similar to the study medication will be administered.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients diagnosed with malignant pleural mesothelioma of epithelial, sarcomatoid or mixed histology, confirmed by histology and / or cytology • The patient may not have received more than two previous systemic therapy regimens. • Patients with an area of ​​pleural cortex thickness of at least 1.0 cm in linear length, determined using the meso-RECIST criteria and modified [10] on a helical computed tomography (CT) scan. • Patients 18 years of age or older. • Patients with a score> 70 on the Karnofsky functional status scale • Patients with adequate bone marrow function who do not use colony stimulating factors today • Patients with adequate coagulation • Patients with adequate liver function • Patients with adequate renal function • Patients must have completed previous chemotherapy or radiotherapy at least 4 weeks before drug administration (6 weeks in the case of nitrosoureas or mitomycin C) and must have recovered from any toxicity related to treatment (grade <1 according to Common terminology criteria for adverse events [CTCAE] of the National Cancer Institute [NCI] or having recovered levels prior to treatment). • Women should be postmenopausal, be sterilized by surgical methods, be willing to use 2 adequate barrier contraceptive methods to prevent pregnancy or agree to abstain from heterosexual sexual activity during the study, from visit 1 and for at least 30 days after the last dose of the study drug. Males should agree to use an appropriate contraceptive method during the study. • Patients who are willing to meet the requirements of the study and who are able to do so, including blood sampling, tumor evaluations and administration of the study drug. • Patients who are able to understand and are willing to sign the informed consent approved by the ethical clinical research committee (CEIC).
Exclusion criteria
Exclusion criteria: • Patients who have received prior treatment with an HDAC inhibitor (eg, depsipeptide, MS-275, LAQ-824, PXD-101 and valproic acid). Patients who have received such drugs for other indications, for example, epilepsy, may participate in vorinostat trials after a 30-day pharmacological rest period. • Patients with active infection for whom they have received antibiotics, antiviral or antifungal intravenously in the two weeks prior to the start of the study drug. • Patients with a second currently active malignant neoplasm other than skin cancer other than melanoma and cervical carcinoma in situ will be excluded. It will be considered that the patient does not have a second malignancy currently active if he has completed the treatment for the second malignant tumor and has not presented the previous malignant disease in the last> 5 years. • Patients with uncontrolled brain metastases, for example, previously treated brain metastases that have not stabilized in the last 6 weeks. • Patients with a known human immunodeficiency virus (HIV) infection or HIV-related malignancy. • Pregnant or nursing patients. • Patients with a known allergy to any of the components of the study drug. • Patients with a history of gastrointestinal surgery or other procedures that may, in the opinion of the investigator, interfere with the absorption or swallowing of the study drug. • Patients with poorly controlled intercurrent diseases or circumstances that may limit study compliance, for example (but not limited to): active infection, acute or chronic graft versus host disease, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia heart or psychiatric diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It will be calculated between the moment of randomization and the moment of death. Patients who do not die during the study will be censored from the analysis at the time of the final visit. Measure:Overall Survival Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Progression-free survival is defined as the time between randomization and the time when the modified meso-RECIST criteria for disease progression are met for the first time or death from any cause occurs. Measure:Survival Without Progression Timepoints:During the study ; Outcome name:Tumor evaluations will be performed by CT at baseline and every 42 days during the first year of treatment and every 84-90 days thereafter until the appearance of signs of disease progression or the start of a new treatment. The tomographs will be sent to an evaluation center. Measure:Objective Response Timepoints:During the study ; Outcome name:The lung function tests will be forced vital capacity (FVC) and maximum expiratory volume in the first second (FEVl). These tests will be performed at baseline (in the two weeks prior to the administration of the drug), in the three days prior to the start of day 1 of cycle 5 (week 12) and after treatment or at the time when it is suspected disease progression, whichever occurs before. Measure:Variation in Pulmonary Function Tests Timepoints:During the study ; Outcome name:The LCSS is a questionnaire to determine disease-related symptoms and health-related quality of life expressly developed for lung cancer [18; 19; 20] and the LCSS-Meso represents a modification of the mesothelioma scale that has been used in an extensive clinical trial [ Measure:Results Reported by Patients Timepoints:During the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed