Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00390611
First received: October 19, 2006
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: Sorafenib
Drug: Paclitaxel
Drug: Carboplatin

  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
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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
Paclitaxel/Carboplatin/Sorafenib Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
Paclitaxel/Carboplatin Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV

Participant Flow for 2 periods

Period 1:   6 Cycles of Study Treatment
    Paclitaxel/Carboplatin/Sorafenib     Paclitaxel/Carboplatin  
STARTED     43     42  
COMPLETED     34     37  
NOT COMPLETED     9     5  

Period 2:   Maintenance Sorafenib to Month 12
    Paclitaxel/Carboplatin/Sorafenib     Paclitaxel/Carboplatin  
STARTED     23 [1]   0 [2]
COMPLETED     13     0  
NOT COMPLETED     10     0  
[1] 11 patients came off-study between the end of cycle 6 and the start of maintenance
[2] Patients in the Paclitaxel/carboplatin arm did not recieve maintenance sorafenib



  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.
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Reporting Groups
  Description
Paclitaxel/Carboplatin/Sorafenib

Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid

Sorafenib

Paclitaxel: Paclitaxel

Carboplatin: Carboplatin

Paclitaxel/Carboplatin

Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV

Paclitaxel: Paclitaxel

Carboplatin: Carboplatin

Total Total of all reporting groups

Baseline Measures
    Paclitaxel/Carboplatin/Sorafenib     Paclitaxel/Carboplatin     Total  
Number of Participants  
[units: participants]
  43     42     85  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 31 to 78 )  
  62  
  ( 42 to 80 )  
  62  
  ( 31 to 80 )  
Gender  
[units: participants]
     
Female     43     42     85  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     43     42     85  



  Outcome Measures
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1.  Primary:   2-year Progression-free Survival   [ Time Frame: 2 years ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 18 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 18 months ]

4.  Secondary:   Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib   [ Time Frame: 18 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00390611     History of Changes
Other Study ID Numbers: SCRI GYN 19, SR05-918
Study First Received: October 19, 2006
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board