None listed
Conditions
Interventions
This group will be treated with: Vorinostat, in capsules, at a dose of 400 mg, PO, QD, days 1 to 14 of each cycle of 21 days (In Cycle 1: Duration of 25 days in days -4 to 10 ). + Paclitaxel, at a dose of 200 mg / m2, in IV infusion for 3h on day 1 of each cycle + Carboplatin, at a dose of 6 mg / ml / min, in IV infusion for 30 minutes on day 1 of each cycle. A maximum of 6 therapy cycles will be administered or until progression of the disease occurs, unacceptable toxicity or withdrawal of cons
This group will be treated with: Vorinostat Placebo, in capsules, PO, QD, days 1 to 14 of each cycle of 21 days (In Cycle 1: Duration of 25 days in days -4 to 10). + Paclitaxel, at a dose of 200 mg / m2, in IV infusion for 3h on day 1 of each cycle + Carboplatin, at a dose of 6 mg / ml / min, in IV infusion for 30 minutes on day 1 of each cycle. A maximum of 6 therapy cycles will be administered or until progression of the disease occurs, unacceptable toxicity or withdrawal of consent.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has a histologically or cytologically confirmed diagnosis of Non-Small Cell Bronchopulmonary Carcinoma (NSCLC) in Stage IIIB or Stage IV. 2. Patients have not received prior systemic chemotherapy, with the exception of adjuvant chemotherapy for NSCLC. 3. The patient is ≥ 18 years of age at the time of providing informed consent. 4. The patient has a measurable disease. 5. It has been at least 3 weeks since the patient underwent any major surgery or previous radiation therapy and has adequately recovered from the toxicity or complications of these interventions. 6. The patient has a performance status of the Oncological Cooperative Group of the East of 0 or 1. 7. Patients have an adequate organic function. 8. Female patient, potentially fertile with a negative pregnancy test within 72 days of enrollment in the study. 9. The patient agrees: 1) To use 2 contraceptive methods suitable to prevent pregnancy or 2) To abstain from the practice of heterosexual activity throughout the study. 10. The patient is available for the periodic extraction of blood samples, evaluations related to the study, and appropriate clinical management at the institution providing the treatment during the course of the study. 11. The patient or his legally authorized representative have voluntarily agreed to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has been treated with an investigational agent for any indication within 4 weeks of enrollment in the study. 2. The patient has an active infection or has received antibacterial, antiviral, or intravenous antifungal drugs within 2 weeks prior to enrollment. 3. The patient has a prior history of treatment with HDAC inhibitors. 4. The patient is receiving systemic steroids by any indication. 5. Patients with untreated brain metastasis or carcinomatous meningitis are excluded. 6. The patient can not take and / or tolerate oral drugs continuously, 7. The patient is infected by the human immunodeficiency virus (HIV) or an HIV-related malignancy. 8. The patient has active hepatitis A, B or C infection. 9. The patient is pregnant or breastfeeding. 10. The patient has a known allergy or hypersensitivity to any component of vorinostat or carboplatin. 11. The patient has a history of gastrointestinal surgery or another procedure that may interfere with the absorption or intake of the study drugs. 12. The patient has an uncontrolled concurrent illness or circumstances that could limit compliance with the study. 13. The patient has a preexisting grade 2 or higher neuropathy. 14. The patient presents a history of previous malignancy. 15. The patient is eligible for treatment with bevacizumab in combination with paclitaxel plus carboplatin, and bevacizumab is available for the individual patient, and treatment with bevacizumab in combination with paclitaxel plus carboplatin is considered the preferred treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the time from the randomization until the moment in which death occurs due to any cause. Measure:General Survival. Timepoints:During the follow-up every 2 months until the death occurs or until the cut-off date for the final analysis, whichever occurs in the first instance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Identification of the time from the randomization until the moment in which the progression of the disease or death due to any cause occurs. The progression of the disease should be confirmed by a second evaluation at 4 weeks or later, unless a confirmatory evaluation is not available. The progression is defined as: 1) At least, a 20% increase in the sum of the larger diameters of the target lesions. or 2) Appearance of one or more new lesions and / or clear progression of existing non-target lesions. Criterion 2: Identification of those patients who have Complete Response (CR) or Partial Response (PR). CR is defined as: 1) Disappearance of all target lesions. OR 2) Disappearance of all non-target lesions and normalization of tumor marker level. PR is defined as: At least a 30% decrease in the sum of the largest diameters of the target lesions. Measure:1) Survival without Progression. 2) Objective Response Index. Timepoints:Survival without Progression: Every 42 days during the first year after discontinuation and then every 84 days. Objective Response Index: Before starting the treatment and every 42 days. ; Outcome name:Criterion 1: Evaluation of adverse events according to the Common Toxicity Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI), version 3.0. Criterion 2: Complete physical examination of all organs and systems. Criterion 3: The general condition according to ECOG, qualifies the patient s activity on a scale of 0 to 5. Criterion 4: Temperature, pulse, respiratory rate and blood pressure. Criterion 5: Panels of hematology and serum chemistry. Criterion 6: standard 12-lead ECG. Measure:Security: 1) Adverse events. 2) Physical examination. 3) General condition. 4) Vital signs. 5) Laboratory tests. 6) ECG. Timepoints:Adverse events: Days -4, 1, 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2 to 6 and during follow-up. Vital signs: Days -4, 1, 8 and 15 of cycle 1, day 1 of cycles 2 | — |
Countries
Australia, Canada, Colombia, Djibouti, Germany, India, Italy, Korea South, Malasya, Mexico, Philippines, Russian Federation, South Africa, Spain, Sweden, Thailand, United Kindgdom, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed