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Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456989
First Posted: April 5, 2007
Last Update Posted: October 9, 2014
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.
Information provided by (Responsible Party):
James Graham Brown Cancer Center
Results First Submitted: October 6, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Taxotere
Drug: Doxil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Reporting Groups
  Description
Taxotere and Doxil

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.


Participant Flow:   Overall Study
    Taxotere and Doxil
STARTED   39 
COMPLETED   39 
NOT COMPLETED   0 



  Baseline Characteristics
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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
  Description
Taxotere and Doxil

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.


Baseline Measures
   Taxotere and Doxil 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age, Customized 
[Units: Participants]
 
>=18   39 
Gender 
[Units: Participants]
 
Female   0 
Male   39 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose and Toxicity Profile   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

2.  Secondary:   Response Rate   [ Time Frame: 7 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Damian Laber
Organization: University of Louisville
phone: 502-562-4369
e-mail: damian.laber@louisville.edu



Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00456989     History of Changes
Other Study ID Numbers: IRB# 575-03
First Submitted: April 4, 2007
First Posted: April 5, 2007
Results First Submitted: October 6, 2014
Results First Posted: October 9, 2014
Last Update Posted: October 9, 2014