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

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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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cabazitaxel and Radiation
Hide Arm/Group Description

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
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Cabazitaxel and Radiation
Hide Arm/Group Description

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
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
61
(56 to 64)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation
Hide Description The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2
Time Frame 2 mos
Hide Outcome Measure Data
Hide Analysis Population Description
while 5 participants were enrolled only 4 completed treatment as patients # 5 only received part of day 1 therapy secondary to an AE and therefore is not included in the assessment.
Arm/Group Title Cabazitaxel and Radiation
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: mg/m2
NA [1] 
[1]
only the 5mg/m2 dose was evaluated due to the study closing early and MTD was not determined)
2.Secondary Outcome
Title 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.
Hide Description Assess toxicity using CTCAE version 4.0. Number of patients who experienced a toxicity on the study. Not all toxicities are related to study treatment. Of note, there were no serious adverse events on this trial.
Time Frame During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cabazitaxel and Radiation
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
Time Frame From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cabazitaxel and Radiation
Hide Arm/Group Description

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
All-Cause Mortality
Cabazitaxel and Radiation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cabazitaxel and Radiation
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cabazitaxel and Radiation
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Investigations   
anemia   2/5 (40.00%)  2
anorexia/decreased appetite   2/5 (40.00%)  2
constipation   1/5 (20.00%)  1
diarrhea   3/5 (60.00%)  3
dizziness   1/5 (20.00%)  1
fatigue   5/5 (100.00%)  5
flatulence   1/5 (20.00%)  1
GI Hemorrhage   1/5 (20.00%)  1
glucose   2/5 (40.00%)  2
hemmorhoids   1/5 (20.00%)  1
Hot flashes   2/5 (40.00%)  2
Hypersensitivity rxn   1/5 (20.00%)  1
Potassium   1/5 (20.00%)  1
Lymphopenia   1/5 (20.00%)  1
myalgia/ malaise   1/5 (20.00%)  1
nausea   2/5 (40.00%)  2
Pain- leg   1/5 (20.00%)  1
pain-abdominal   1/5 (20.00%)  1
urinary frequency   2/5 (40.00%)  2
WBC   1/5 (20.00%)  1
Aches   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
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
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