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Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00017563
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : August 31, 2011
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: docetaxel
Drug: mitoxantrone hydrochloride
Procedure: conventional surgery
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel and Mitox
Hide Arm/Group Description

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Period Title: Overall Study
Started 57
Completed 56
Not Completed 1
Arm/Group Title Docetaxel and Mitox
Hide Arm/Group Description

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
  68.4%
>=65 years
18
  31.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
61.56  (6.279)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
0
   0.0%
Male
57
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants
57
1.Primary Outcome
Title Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
Hide Description Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Time Frame Every 3 months after surgery for up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel and Mitox
Hide Arm/Group Description:

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
30
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel and Mitox
Hide Arm/Group Description

Drug: docetaxel

35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.

Drug: mitoxantrone hydrochloride

Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.

All-Cause Mortality
Docetaxel and Mitox
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel and Mitox
Affected / at Risk (%)
Total   43/57 (75.44%) 
Blood and lymphatic system disorders   
Neutropenia  18/57 (31.58%) 
Leukopenia  21/57 (36.84%) 
Gastrointestinal disorders   
Abdominal Pain  1/57 (1.75%) 
Diarrhea  3/57 (5.26%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel and Mitox
Affected / at Risk (%)
Total   57/57 (100.00%) 
Blood and lymphatic system disorders   
Anemia  3/57 (5.26%) 
Hypophosphatemia  5/57 (8.77%) 
Eye disorders   
Hyperlacrimation  4/57 (7.02%) 
Vision  3/57 (5.26%) 
General disorders   
Fatigue  8/57 (14.04%) 
Taste Disturbance  4/57 (7.02%) 
Metabolism and nutrition disorders   
Hyperglycemia  11/57 (19.30%) 
Skin and subcutaneous tissue disorders   
Dermatology-Skin Toxicity  3/57 (5.26%) 
Alopecia  10/57 (17.54%) 
Onycholysis  17/57 (29.82%) 
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: Tomasz Beer, M.D.
Organization: OHSU Knight Cancer Institute
Phone: 503-494-1080
Responsible Party: Tom Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00017563     History of Changes
Other Study ID Numbers: CDR0000068719
OHSU-2794 ( Other Identifier: OHSU IRB )
OHSU-HOR-00037-L
NCI-G01-1962
First Submitted: June 6, 2001
First Posted: January 27, 2003
Results First Submitted: May 31, 2011
Results First Posted: August 31, 2011
Last Update Posted: April 28, 2017