Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy. At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes
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 20 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
20mg IV over 1 hour every 3 weeks
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
Number of Participants With Progression at the 3 Month Follow up Visit
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit
Time frame: 3 months
Duration of Event Free Survival of Subjects Treated With Cabazitaxel
To examine other measures of efficacy such as overall progression free in all evaluable patients
Time frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Percent of Participants Treated With Cabazitaxel With Event Free Survival
To examine other measures of efficacy such as overall survival in all evaluable patients
Time frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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