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

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ClinicalTrials.gov Identifier: NCT01981668
Recruitment Status : Withdrawn (no Canadian centre interested in conducting study in a reasonable timeframe)
First Posted : November 11, 2013
Last Update Posted : March 19, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Derek R Wilke MD,MSc,FRCPC, Nova Scotia Cancer Centre

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: cabazitaxel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arm Intervention/treatment
Experimental: 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.
Drug: cabazitaxel
Concurrent cabazitaxel, radiotherapy and Eligard for 3 years
Other Name: Jevtana




Primary Outcome Measures :
  1. Toxicity [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk prostate cancer

Exclusion Criteria:

  • mets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981668


Sponsors and Collaborators
Nova Scotia Cancer Centre
Sanofi
Investigators
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Principal Investigator: Derek R Wilke, MD,MSc,FRCPC department of radiation oncology

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Responsible Party: Derek R Wilke MD,MSc,FRCPC, Research Director, Nova Scotia Cancer Centre
ClinicalTrials.gov Identifier: NCT01981668    
Other Study ID Numbers: CABAZ-L-06233
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs