Trial Outcomes & Findings for Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer (NCT NCT00500110)

NCT ID: NCT00500110

Last Updated: 2015-04-28

Results Overview

Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: Every 3 months for 1 year, then every 6 months until disease progression or death
• Results posted on: 2015-04-28

Participant Flow

Recruitment at Medical Clinic from 6/13/03 to 11/29/04.

Participant milestones

Measure	Hormonal Ablation, Imatinib + Docetaxel Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Hormonal Ablation, Imatinib + Docetaxel Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Hormonal Ablation, Imatinib + Docetaxel n=39 Participants Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 months for 1 year, then every 6 months until disease progression or death

Population: Analysis was per protocol.

Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.

Outcome measures

Measure	Treatment n=36 Participants
Number of Participants Achieving Pathological Complete Response	0 participants

Adverse Events

Hormonal Ablation, Imatinib + Docetaxel

Serious events: 9 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hormonal Ablation, Imatinib + Docetaxel n=36 participants at risk Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Investigations Alanine aminotransferase	2.8% 1/36 • Number of events 1 • 6 years and 3 months
General disorders Fatigue	2.8% 1/36 • Number of events 1 • 6 years and 3 months
Blood and lymphatic system disorders Febrile neutropenia	2.8% 1/36 • Number of events 1 • 6 years and 3 months
Cardiac disorders acute coronary syndrome	2.8% 1/36 • Number of events 1 • 6 years and 3 months
General disorders fever	2.8% 1/36 • Number of events 1 • 6 years and 3 months
Investigations neutrophil count decreased	2.8% 1/36 • Number of events 1 • 6 years and 3 months
Vascular disorders thrombosis/embolism	5.6% 2/36 • Number of events 2 • 6 years and 3 months
Gastrointestinal disorders vomiting	2.8% 1/36 • Number of events 1 • 6 years and 3 months

Other adverse events

Measure	Hormonal Ablation, Imatinib + Docetaxel n=36 participants at risk Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
Investigations alanine transaminase	16.7% 6/36 • Number of events 6 • 6 years and 3 months
Gastrointestinal disorders diarrhea	11.1% 4/36 • Number of events 8 • 6 years and 3 months
Respiratory, thoracic and mediastinal disorders dyspnea	13.9% 5/36 • Number of events 5 • 6 years and 3 months
General disorders fatigue	44.4% 16/36 • Number of events 22 • 6 years and 3 months
Skin and subcutaneous tissue disorders rash	25.0% 9/36 • Number of events 13 • 6 years and 3 months

Additional Information

Quality Assurance Specialist

MD Anderson Cancer Center

Phone: 713-563-1602

Email: caperez@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place