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Trial record 21 of 2029 for:    doxil

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

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ClinicalTrials.gov Identifier: NCT00456989
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : October 9, 2014
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
University of Louisville

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
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Taxotere and Doxil
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Taxotere and Doxil
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>=18 Number Analyzed 39 participants
39
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
0
   0.0%
Male
39
 100.0%
1.Primary Outcome
Title Maximum Tolerated Dose and Toxicity Profile
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study
Arm/Group Title Taxotere and Doxil
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Response Rate
Hide Description Data not analyzed, PI left institution
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
There is no data to report. Data for this trial was not analyzed, the PI left institution.
Arm/Group Title Taxotere and Doxil
Hide Arm/Group Description:

There is no data to report. Data for this trial was not analyzed, the PI left institution.

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.

There is no data to report. Data for this trial was

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Taxotere and Doxil
Hide Arm/Group Description

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.

All-Cause Mortality
Taxotere and Doxil
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Taxotere and Doxil
Affected / at Risk (%) # Events
Total   8/39 (20.51%)    
Gastrointestinal disorders   
Diarrhea *  1/39 (2.56%)  1
General disorders   
Fatique *  2/39 (5.13%)  2
Fever *  1/39 (2.56%)  1
Bleeding *  2/39 (5.13%)  2
Mouth pain *  1/39 (2.56%)  1
Infections and infestations   
Bacterial meningitis *  1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Taxotere and Doxil
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: University of Louisville, James Graham Brown Cancer Center Clinical Trials
Organization: University of Louisville, James Graham Brown Cancer Center
Phone: 502-562-3429
EMail: ctobcc@louisville.edu
Layout table for additonal information
Responsible Party: University of Louisville
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 30, 2019