Trial Outcomes & Findings for Docetaxel in Treating Patients With Relapsed Prostate Cancer (NCT NCT00482274)

Results Overview

Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

While receiving study treatment (approximately 6 months)

Results posted on

2017-04-28

Participant Flow

Three subjects were enrolled between 11/08 and 4/09 from the oncology clinic at OHSU. Enrollment was terminated on 11/30/09, when the sponsor withdrew funding for this study.

Participant milestones

Participant milestones
Measure	Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
Overall Study Adverse Event	1

Baseline Characteristics

Docetaxel in Treating Patients With Relapsed Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel n=3 Participants Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 2.49 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: While receiving study treatment (approximately 6 months)

Population: Analysis includes all subjects who completed study regimen of 6 cycles.

Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.

Outcome measures

Outcome measures
Measure	Docetaxel n=2 Participants Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml	1 participants

SECONDARY outcome

Timeframe: Average days to develop recurrence from treatment start date amount applicable participants

Population: Due to the limited enrollment, this analysis was not completed.

Average time for participants to develop PSA recurrence (PSA \> 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Time of documented metastases (no historical estimate is available)

Population: Due to limited enrollment, this analysis was not completed

Due to the limited enrollment, this analysis was not completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at date of documented androgen independence (no estimate available)

Population: Due to the limited enrollment, this analysis was not completed.

Due to the limited enrollment, this analysis was not completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at date of death (no estimate available)

Population: Due to the limited enrollment, this analysis was not completed.

Due to the limited enrollment, this analysis was not completed.

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Docetaxel n=3 participants at risk Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
General disorders Fatigue	66.7% 2/3 • Number of events 2
General disorders alopecia	33.3% 1/3 • Number of events 1
General disorders pain	33.3% 1/3 • Number of events 1
General disorders insomnia	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders hyperpigmentation	33.3% 1/3 • Number of events 1
Eye disorders watering eyes	33.3% 1/3 • Number of events 1

Additional Information

Study Coordinator

Oregon Health & Science University Knight Cancer Institute

Phone: 503 494-2897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place