ClinicalTrials.gov
ClinicalTrials.gov Menu

Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01650285
Recruitment Status : Terminated
First Posted : July 26, 2012
Results First Posted : June 29, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Cabazitaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cabazitaxel and Radiation

Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.

Cabazitaxel: Dose Level Day 1, 22, 43

  1. 5.0 mg/m2
  2. 10.0 mg/m2
  3. 15.0 mg/m2
  4. 20.0 mg/m2

Participant Flow:   Overall Study
    Cabazitaxel and Radiation
STARTED   5 
COMPLETED   4 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cabazitaxel and Radiation

Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.

Cabazitaxel: Dose Level Day 1, 22, 43

  1. 5.0 mg/m2
  2. 10.0 mg/m2
  3. 15.0 mg/m2
  4. 20.0 mg/m2

Baseline Measures
   Cabazitaxel and Radiation 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Years]
Mean (Full Range)
 61 
 (56 to 64) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      5 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation   [ Time Frame: 2 mos ]

2.  Secondary:   Number of Participants Experiencing a Toxicity Associated With Cabazitaxel and Adjuvant Radiation Following Prostatectomy for Patients With Stage 3 Prostate Cancer and for Patients With a PSA Elevation Post–Prostatectomy.   [ Time Frame: During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anthony Mega
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu



Responsible Party: Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier: NCT01650285     History of Changes
Other Study ID Numbers: BrUOG 246
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: July 14, 2014
Results First Posted: June 29, 2015
Last Update Posted: July 17, 2018