Carboplatin, Everolimus, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Progressed After Docetaxel

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01051570
First received: January 15, 2010
Last updated: August 9, 2014
Last verified: August 2014
Results First Received: August 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: carboplatin
Drug: RAD 001
Drug: prednisone
Other: laboratory biomarker analysis
Other: pharmacological study

  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
Carboplatin, RAD 001 & Prednisone

Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle

RAD 001: 5 mg Orally daily, starting from Day 2 continuously

Prednisone 5 mg Orally twice daily, continuously

carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle

RAD 001: 5 mg orally starting on Day 2 then continuous

prednisone: 5 mg orally twice a day starting on Day 1 then continuous

laboratory biomarker analysis: Samples will be collected from archival tissue.

pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2


Participant Flow:   Overall Study
    Carboplatin, RAD 001 & Prednisone  
STARTED     26  
COMPLETED     26  
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
Carboplatin, RAD 001 & Prednisone

Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle

RAD 001: 5 mg Orally daily, starting from Day 2 continuously

Prednisone 5 mg Orally twice daily, continuously

carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle

RAD 001: 5 mg orally starting on Day 2 then continuous

prednisone: 5 mg orally twice a day starting on Day 1 then continuous

laboratory biomarker analysis: Samples will be collected from archival tissue.

pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2


Baseline Measures
    Carboplatin, RAD 001 & Prednisone  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Median ( Full Range )
  69  
  ( 54 to 86 )  
Gender  
[units: participants]
 
Female     0  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures

1.  Primary:   Time to Progression (TTP)   [ Time Frame: Every 3 cycles (cycle = 21 days) ]

2.  Secondary:   Toxicity as Measured by NCI CTCAE v3.0 Criteria   [ Time Frame: Day 1 of each cycle (every 21 days) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   PSA Response Rate   [ Time Frame: Day 1 of each cycle (every 21 days) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Association of TTP and PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)   [ Time Frame: Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Pharmacokinetics   [ Time Frame: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Overall Survival   [ Time Frame: After treatment, participants will be contacted every 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
Small sample size; Correlates were conducted in <50% of the patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ulka N. Vaishampayan, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: 313-576-8718
e-mail: vaishamu@karmanos.org


No publications provided


Responsible Party: Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01051570     History of Changes
Other Study ID Numbers: CDR0000663630, P30CA022453, WSU-2009-087, NOVARTIS-WSU-2009-087
Study First Received: January 15, 2010
Results First Received: August 9, 2014
Last Updated: August 9, 2014
Health Authority: United States: Food and Drug Administration