Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Columbia, Missouri, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Germantown, Tennessee, United States
Unnamed facility
Gabrovo, Bulgaria
Unnamed facility
Plovidv, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Veliko Tarnovo, Bulgaria
Unnamed facility
Elblag, Poland
...and 32 more locations
Overall Survival
Time frame: throughout study
Progression Free Survival
Time frame: Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment
Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline
Time frame: throughout the study
Incidence of NCI-CTCAE grade 2,3, or 4 anemia
Time frame: throughout the study
Proportion of patients having no impact of chemotherapy-induced emesis on daily life
Time frame: throughout the study
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