A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
- Conditions
- -C439 Malignant melanoma of skin, unspecifiedMalignant melanoma of skin, unspecifiedC439
- Registration Number
- PER-050-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method