The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation

Prostatic Neoplasms Clinical Trial

Official title:

The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01981668
• Other study ID #: CABAZ-L-06233
• Status: Withdrawn
• Phase: Phase 1
• First received: October 29, 2013
• Last updated: March 18, 2014

Study information

• Verified date: March 2014
• Source: Nova Scotia Cancer Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High risk prostate cancer

Exclusion Criteria:

• mets

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• cabazitaxel
Concurrent cabazitaxel, radiotherapy and Eligard for 3 years

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Cancer Centre	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		1 year	Yes