Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126503
First received: August 2, 2005
Last updated: March 19, 2014
Last verified: March 2014
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Biological: bevacizumab
Drug: sorafenib tosylate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This Phase I/II study was open 5/2005 through 12/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
73 patients consented, 4 of whom were determined to be ineligible.

Reporting Groups
  Description
Phase I Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
Phase II Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.

Participant Flow:   Overall Study
    Phase I     Phase II  
STARTED     48     21  
COMPLETED     1     0  
NOT COMPLETED     47     21  
disease progression                 23                 14  
Withdrawal by Subject                 0                 1  
alternative therapy                 1                 1  
other complicating disease                 4                 1  
Death                 3                 0  
Adverse Event                 13                 3  
non-compliant                 1                 0  
Physician Decision                 2                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Phase I Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
Phase II Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
Total Total of all reporting groups

Baseline Measures
    Phase I     Phase II     Total  
Number of Participants  
[units: participants]
  48     21     69  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     19     54  
>=65 years     13     2     15  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 1     58  ± 1     62  ± 1  
Gender  
[units: participants]
     
Female     8     7     15  
Male     40     14     54  
Region of Enrollment  
[units: participants]
     
United States     48     21     69  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)   [ Time Frame: at 28 days ]

2.  Primary:   Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)   [ Time Frame: at 28 days ]

3.  Primary:   Objective Response   [ Time Frame: Every 8 weeks to date of progression ]

4.  Secondary:   Overall Survival   [ Time Frame: on-study to date of expired or last date known alive ]

5.  Secondary:   Progression-free Survival   [ Time Frame: on-study to date of progression or last date known alive without progression ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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


Limitations and Caveats
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
To depict results of this Phases I/II study accurately, each phase was entered as an ARM to enable separation of the data by phase. Events reported in the Adverse Event and Serious Adverse Event sections include AEs and SAEs from Phase I and Phase II  


Results Point of Contact:  
Name/Title: Jeffrey Sosman, MD
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-3048
e-mail: jeff.sosman@vanderbilt.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126503     History of Changes
Other Study ID Numbers: NCI-2009-00066, NCI-2009-00066, CDR0000434814, URO 470, 6555, U01CA099177, P30CA068485
Study First Received: August 2, 2005
Results First Received: November 16, 2012
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration