The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Nova Scotia Cancer Centre
- Primary Endpoint
- Toxicity
Study Overview
Brief Summary
This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.
Detailed Description
This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.
Assuming that dose-limiting toxicity is not encountered, and both the maximum dose of Cabazitaxel is reached, in Part A of the study, and the maximum dose of Radiotherapy is reached in Part B of the study, the maximum number of patients required is as follows: Clinical Study Protocol - The JET study Date: September 11, 2012 Part A: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of Cabazitaxel = 15 + 3 = 18 Part B: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of Radiotherapy = 9 + 3 = 12 The total number of patients required is 30. Patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than DLT will be replaced.
Given our experience in chemo-radiation studies in a similar patient population, our Centre is anticipated to accrue 3 patients per month.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •High risk prostate cancer
Exclusion Criteria
- Not provided
Arms & Interventions
Cabazitaxel, Eligard and Radiotherapy
This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the MTD of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.
Intervention: cabazitaxel (Drug)
Outcomes
Primary Outcomes
Toxicity
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Derek R Wilke MD,MSc,FRCPC
Research Director
Nova Scotia Cancer Centre