An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Prior to initiating protocol therapy, patients will undergo screening evaluations, to be
done within 30 days of protocol initiation unless otherwise noted.
Patients who are taxane naïve will be assigned to arm A and patients who have had prior
taxane therapy will be assigned to Arm B. Each arm will be analyzed separately for the
primary study endpoint of 3 month progression free survival rate (PFS), as defined as the
time from the start of treatment to the date of disease progression or death. Cabazitaxel
will be administered 25 mg/m2 IV over 1 hour every 3 weeks.
In the absence of treatment delays due to adverse event(s), treatment may continue until
disease progression; intercurrent illness that prevents further administration of treatment;
unacceptable adverse event(s); patient decides to withdraw; general or specific changes in
the patient's condition render the patient unacceptable for further treatment in the
judgment of the investigator.
Patients will be followed for 6 months after removal from study or until death, whichever
occurs first. Patients removed from study for unacceptable adverse events will be followed
until resolution or stabilization of the adverse event.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to cabazitaxel
To demonstrate the antitumor activity as assessed by the rate of progression free survival at three months of the sanofi-aventis product cabazitaxel 25mg/m2 IV over 1 hour every 3 weeks in subjects with previously treated metastatic gastroesophageal adenocarcinoma who are either taxane naïve, or taxane previously treated.
estimation of 4 years to determine response on all subjects
Manish Shah, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|