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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01051570
First received: January 15, 2010
Last updated: April 14, 2016
Last verified: April 2016
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 
Overall Participants Analyzed 
[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: Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease. ]

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


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

Responsible Party: Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01051570     History of Changes
Other Study ID Numbers: CDR0000663630
P30CA022453 ( US NIH Grant/Contract Award Number )
WSU-2009-087
NOVARTIS-WSU-2009-087
Study First Received: January 15, 2010
Results First Received: August 9, 2014
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration