Trial Outcomes & Findings for Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy (NCT NCT00589420)

Last Updated: 2022-02-17

Results Overview

PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression. PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

From start of treatment until withdrawal from the study, approximately 12 months

Results posted on

2022-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Phase II Trial of Sorafenib and Docetaxel All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II Trial of Sorafenib and Docetaxel All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Overall Study screen failure	1

Baseline Characteristics

Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib and Docetaxel n=17 Participants All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Age, Continuous	66 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: From start of treatment until withdrawal from the study, approximately 12 months

Outcome measures

Outcome measures
Measure	Phase II Trial of Sorafenib and Docetaxel n=17 Participants All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Prostate Specific Antigen (PSA) Response Rate	6 Participants

SECONDARY outcome

Timeframe: 6 months from end of treatment

Number of patients that achieved 6 month PFS

Outcome measures

Outcome measures
Measure	Phase II Trial of Sorafenib and Docetaxel n=17 Participants All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
6-month Progression-free Survival (PFS)	10 Participants

SECONDARY outcome

Timeframe: 6 months from end of treatment

To determine the ORR in patients with measurable disease

Outcome measures

Outcome measures
Measure	Phase II Trial of Sorafenib and Docetaxel n=18 Participants All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Objective Response Rate (ORR)	3 Participants

Adverse Events

Phase II Trial of Sorafenib and Docetaxel

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase II Trial of Sorafenib and Docetaxel n=17 participants at risk All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks docetaxel sorafenib tosylate
Blood and lymphatic system disorders anemia	17.6% 3/17 • Number of events 3 • first treatment through study completion, approximately 12 months
Metabolism and nutrition disorders anorexia	5.9% 1/17 • Number of events 1 • first treatment through study completion, approximately 12 months
Gastrointestinal disorders diarreha	5.9% 1/17 • Number of events 1 • first treatment through study completion, approximately 12 months
Metabolism and nutrition disorders fatigue	17.6% 3/17 • Number of events 3 • first treatment through study completion, approximately 12 months
Skin and subcutaneous tissue disorders hand-foot syndrome	17.6% 3/17 • Number of events 3 • first treatment through study completion, approximately 12 months
Cardiac disorders hypertension	5.9% 1/17 • Number of events 1 • first treatment through study completion, approximately 12 months
Blood and lymphatic system disorders lymphopenia	29.4% 5/17 • Number of events 5 • first treatment through study completion, approximately 12 months
Gastrointestinal disorders nausea	11.8% 2/17 • Number of events 2 • first treatment through study completion, approximately 12 months
Blood and lymphatic system disorders neutropenia	100.0% 17/17 • Number of events 17 • first treatment through study completion, approximately 12 months
Infections and infestations pneumonia	5.9% 1/17 • Number of events 1 • first treatment through study completion, approximately 12 months
Skin and subcutaneous tissue disorders Rash	17.6% 3/17 • Number of events 3 • first treatment through study completion, approximately 12 months
Metabolism and nutrition disorders Weight Loss	17.6% 3/17 • Number of events 3 • first treatment through study completion, approximately 12 months

Additional Information

Ravi Amaravadi

Abramson Cancer Center

Phone: 2156622222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place