Trial Outcomes & Findings for Cabazitaxel and Radiation For Patients With Prostate Cancer (NCT NCT01650285)

Last Updated: 2022-03-04

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

2 mos

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	1

Baseline Characteristics

Cabazitaxel and Radiation For Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabazitaxel and Radiation n=5 Participants 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
Age, Continuous	61 years n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: 2 mos

Population: 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.

Outcome measures

Outcome measures
Measure	Cabazitaxel and Radiation n=4 Participants 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
Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation	NA mg/m2 only the 5mg/m2 dose was evaluated due to the study closing early and MTD was not determined)

SECONDARY outcome

Timeframe: During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.

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.

Outcome measures

Outcome measures
Measure	Cabazitaxel and Radiation n=5 Participants 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
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.	5 Participants

Adverse Events

Cabazitaxel and Radiation

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cabazitaxel and Radiation n=5 participants at risk 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
Investigations anemia	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations anorexia/decreased appetite	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations constipation	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations diarrhea	60.0% 3/5 • Number of events 3 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations dizziness	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations fatigue	100.0% 5/5 • Number of events 5 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations flatulence	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations GI Hemorrhage	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations glucose	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations hemmorhoids	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Hot flashes	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Hypersensitivity rxn	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Potassium	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Lymphopenia	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations myalgia/ malaise	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations nausea	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Pain- leg	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations pain-abdominal	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations urinary frequency	40.0% 2/5 • Number of events 2 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations WBC	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.
Investigations Aches	20.0% 1/5 • Number of events 1 • From time of informed consent to approximately 30 days post last dose of drug- approximately 3 months.

Additional Information

Dr. Anthony Mega

BrUOG

Phone: 4018633000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place