Docetaxel in Treating Patients With Relapsed Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00482274
Recruitment Status : Terminated (Drug supplier stopped funding due to loss of study drug (docetaxel) patent.)
First Posted : June 5, 2007
Results First Posted : August 24, 2010
Last Update Posted : April 28, 2017
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
Intervention: Drug: docetaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.

Participant Flow:   Overall Study
Adverse Event                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1  33.3% 
>=65 years      2  66.7% 
[Units: Years]
Mean (Standard Deviation)
 66  (2.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      3 100.0% 
Region of Enrollment 
[Units: Participants]
United States   3 

  Outcome Measures

1.  Primary:   Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml   [ Time Frame: While receiving study treatment (approximately 6 months) ]

2.  Secondary:   Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)   [ Time Frame: Average days to develop recurrence from treatment start date amount applicable participants ]

3.  Secondary:   Time to Metastatic Disease   [ Time Frame: Measured at Time of documented metastases (no historical estimate is available) ]

4.  Secondary:   Time to Androgen Independent State   [ Time Frame: Measured at date of documented androgen independence (no estimate available) ]

5.  Secondary:   Time to Death From Any Cause   [ Time Frame: measured at date of death (no estimate available) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to withdrawal of sponsor support, this study was terminated after only 3 subjects were enrolled (of the planned 36 subjects). Sufficient data were not obtained to make statistically significant conclusions.

  More Information

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: Study Coordinator
Organization: Oregon Health & Science University Knight Cancer Institute
phone: 503 494-2897

Responsible Party: Tom Beer, OHSU Knight Cancer Institute Identifier: NCT00482274     History of Changes
Other Study ID Numbers: CDR0000546975
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-2838 ( Other Identifier: OHSU IRB )
OHSU-SOL-06076-LM ( Other Identifier: OHSU Knight Cancer Institute )
First Submitted: June 4, 2007
First Posted: June 5, 2007
Results First Submitted: July 27, 2010
Results First Posted: August 24, 2010
Last Update Posted: April 28, 2017