Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00423449
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment
- Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vorinostat + Gemcitabine + Platinum-based agent Platinum-based agent - Vorinostat + Gemcitabine + Platinum-based agent Gemcitabine - Vorinostat + Gemcitabine + Platinum-based agent vorinostat -
- Primary Outcome Measures
Name Time Method Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin every 21 days (every cycle), up to 126 days (6 cycles) DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting \>=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of \>=1 study drugs.
Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease every 21 days (every cycle), up to 126 days (6 cycles) Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.
The MTD was 400 mg for up to 10 days in 21-day cycles.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Adverse Experiences (Safety and Tolerability) every 21 days (every cycle), up to 126 days (6 cycles) An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability) every 21 days (every cycle), up to 126 days (6 cycles) An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively).