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S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134056
First Posted: August 24, 2005
Last Update Posted: June 2, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Metastatic Cancer
Prostate Cancer
Interventions: Drug: atrasentan hydrochloride
Drug: docetaxel
Drug: prednisone
Other: placebo

  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
Arm I: Placebo

Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.

docetaxel: Docetaxel given IV and prednisone given orally

prednisone: Docetaxel given IV and prednisone given orally

placebo: Given orally

Arm II: Atrasentan

Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.

atrasentan hydrochloride: Given orally

docetaxel: Docetaxel given IV and prednisone given orally

prednisone: Docetaxel given IV and prednisone given orally


Participant Flow for 2 periods

Period 1:   Randomization
    Arm I: Placebo   Arm II: Atrasentan
STARTED   518   520 
COMPLETED   496   500 
NOT COMPLETED   22   20 
Not eligible for assigned treatment                22                20 

Period 2:   Eligible for Protocol Assigned Treatment
    Arm I: Placebo   Arm II: Atrasentan
STARTED   496   500 
COMPLETED   169   185 
NOT COMPLETED   327   315 
Lack of Efficacy                171                171 
Adverse Event                81                67 
Withdrawal by Subject                20                21 
Not specified                55                56 



  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.
A total of 1038 patients were randomized to this study, 42 of which were ineligible. Baseline analysis population includes 994 patients (excluding the 42 ineligible patients and 2 additional patients who withdrew all consent prior to receiving protocol treatment).

Reporting Groups
  Description
Arm I: Placebo

Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.

docetaxel: Docetaxel given IV and prednisone given orally

prednisone: Docetaxel given IV and prednisone given orally

placebo: Given orally

Arm II: Atrasentan

Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.

atrasentan hydrochloride: Given orally

docetaxel: Docetaxel given IV and prednisone given orally

prednisone: Docetaxel given IV and prednisone given orally

Total Total of all reporting groups

Baseline Measures
   Arm I: Placebo   Arm II: Atrasentan   Total 
Overall Participants Analyzed 
[Units: Participants]
 496   498   994 
Age 
[Units: Years]
Median (Full Range)
 69 
 (43 to 89) 
 69 
 (40 to 92) 
 69 
 (40 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      496 100.0%      498 100.0%      994 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      20   4.0%      21   4.2%      41   4.1% 
Not Hispanic or Latino      476  96.0%      477  95.8%      953  95.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   403   403   806 
Black   64   73   137 
Asian   12   8   20 
Unknown   14   10   24 
Serum PSA 
[Units: ug/L]
Median (Inter-Quartile Range)
 67.7 
 (24.6 to 202.4) 
 79.0 
 (23.5 to 228.3) 
 72.7 
 (24.4 to 213.8) 
Type of Progression at study entry 
[Units: Participants]
Count of Participants
     
Measurable or evaluable      394  79.4%      407  81.7%      801  80.6% 
PSA increase only      102  20.6%      91  18.3%      193  19.4% 
Bisphosphonate use at study entry 
[Units: Participants]
Count of Participants
 305   304   609 
Brief Pain Inventory, worst pain [1] 
[Units: Participants]
Count of Participants
     
>= 4      213  42.9%      210  42.2%      423  42.6% 
<4      283  57.1%      288  57.8%      571  57.4% 
[1] score >=4 vs <4 in the Brief Pain Inventory scale for worst pain
Metastases 
[Units: Participants]
Count of Participants
     
Skeletal only      206  41.5%      203  40.8%      409  41.1% 
Lymph nodes      148  29.8%      149  29.9%      297  29.9% 
Lung, liver or brain      94  19.0%      101  20.3%      195  19.6% 
Extraskeletal      48   9.7%      45   9.0%      93   9.4% 
Previous prostatectomy 
[Units: Participants]
Count of Participants
 145   168   313 
Performance status [1] 
[Units: Participants]
Count of Participants
     
2-3      39   7.9%      36   7.2%      75   7.5% 
0-1      457  92.1%      462  92.8%      919  92.5% 
[1]

SWOG Performance status:

0 = Fully active, able to carry on all pre-disease performance without restriction.

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
  2. = Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
  3. = Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
Gleason score [1] 
[Units: Participants]
Count of Participants
     
5-6      49   9.9%      52  10.4%      101  10.2% 
    137  27.6%      141  28.3%      278  28.0% 
8-10      272  54.8%      275  55.2%      547  55.0% 
Missing      38   7.7%      30   6.0%      68   6.8% 
[1]

Pathologists grade prostate cancers using numbers from 1 to 5 based on how much the cells in the cancerous tissue look like normal tissue. This is called the Gleason system.

If the cancerous tissue looks like normal tissue, a grade of 1 is assigned. If the cancer cells look very abnormal, a grade of 5 is assigned. Grades 2-4 have features in between these extremes.

Since prostate cancers often have areas with different grades, a grade is assigned to the 2 areas that make up most of the cancer. These 2 grades are added to yield the Gleason score. The highest a Gleason score can be is 10.



  Outcome Measures
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1.  Primary:   Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.   [ Time Frame: Up to 7 years after study opens ]

2.  Primary:   Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.   [ Time Frame: Up to 7 years after study opens ]

3.  Secondary:   Compare Pain Progression Between the Two Study Arms.   [ Time Frame: Up to 52 weeks ]

4.  Secondary:   Compare Qualitative and Quantitative Toxicity Between the Two Study Arms   [ Time Frame: Assessed every 3 weeks up to 52 weeks ]

5.  Secondary:   Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.   [ Time Frame: Up to 7 years after study opens ]

6.  Secondary:   Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.   [ Time Frame: Up to 52 weeks ]

7.  Other Pre-specified:   Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)   [ Time Frame: up to 18 months study period ]

8.  Other Pre-specified:   Number of Patients With a Change in Functional Status   [ Time Frame: up to 18 months study period ]


  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. David I Quinn
Organization: University of Southern California Norris Comprehensive Cancer Center
phone: 3238653956
e-mail: diquinn@med.usc.edu


Publications of Results:
Goldkorn A, Ely B, Quinn DI, et al.: Results of telomerase activity measurements from live circulating tumor cells captured on a slot microfilter in a phase III SWOG-coordinated prostate cancer trial (S0421). [Abstract] J Clin Oncol 30 (Suppl 15): A-4663, 2012.
Lara P, Ely B, Quinn DI, et al.: SWOG 0421: prognostic and predictive value of bone metabolism biomarkers (BMB) in castration resistant prostate cancer (CRPC) patients (pts) with skeletal metastases treated with docetaxel (DOC) with or without atrasentan (ATR). [Abstract] J Clin Oncol 30 (Suppl 15): A-4547, 2012.
Quinn DI, Tangen CM, Hussain M, et al.: SWOG S0421: phase III study of docetaxel (D) and atrasentan (A) versus docetaxel and placebo (P) for men with advanced castrate resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 30 (Suppl 15): A-4511, 2012.
Goldkorn A, Xu T, Lu B, et al.: Circulating tumor cell capture and analysis in a multicenter SWOG-coordinated prostate cancer trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS342, 2010.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00134056     History of Changes
Other Study ID Numbers: CDR0000439434
S0421 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: January 4, 2017
Results First Posted: May 2, 2017
Last Update Posted: June 2, 2017



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