Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Cabazitaxel will be administered 25 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
Distal Esophageal Adenocarcinoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma|
- Response to cabazitaxel [ Time Frame: estimation of 4 years to determine response on all subjects ] [ Designated as safety issue: No ]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.
- Event free survival of subjects treated with cabazitaxel [ Time Frame: Approximately 4 years to assess response on all subjects accrued to the study ] [ Designated as safety issue: No ]To examine other measures of efficacy including overall progression free and overall survival in all evaluable patients, and the objective response rate in patients with measurable disease.
- Toxicity profile of cabazitaxel. [ Time Frame: Approximated 4 years to obtain safety data for all subjects. ] [ Designated as safety issue: Yes ]The frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE v. 4.0. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimate
- Response to cabazitaxel across gastric cancer subtypes. [ Time Frame: Approximately 4 years to obtain efficacy data on all subjects. ] [ Designated as safety issue: No ]Response will be measured by the disappearance of the sum of the diameters of all target lesions observed on CT/MRI scan.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A (taxane naïve)
No prior Taxane treatment. Cabazitaxel will be administered 25 mg/m2 IV over 1 hour every 3 weeks
25mg IV over 1 hour every 3 weeks
Experimental: Arm B (prior taxane therapy)
Subject previously treated with taxane. Cabazitaxel will be administered 25 mg/m2 IV over 1 hour every 3 weeks
25mg IV over 1 hour every 3 weeks
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.
|Contact: Alice Mercado, RNfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Manish Shah, MD 646-962-2547|
|Principal Investigator:||Manish Shah, MD||Weill Medical College of Cornell University|