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Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer (SorCape)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471353
First Posted: November 16, 2011
Last Update Posted: August 23, 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.
Information provided by (Responsible Party):
University of Florida
Results First Submitted: November 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer Metastatic
Intervention: Drug: Sorafenib Plus Capecitabine (SorCape)

  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
43 Patients were consented and enrolled; however, only 42 were dosed. The one patient that was not dosed was removed due to progression of disease prior to treatment initiation.

Reporting Groups
  Description
Sorafenib Plus Capecitabine (SorCape)

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days


Participant Flow:   Overall Study
    Sorafenib Plus Capecitabine (SorCape)
STARTED   42 
COMPLETED   39 
NOT COMPLETED   3 
remain on study                3 



  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.
Adults with metastatic colorectal cancer who had previously received two or more lines of systemic therapy.

Reporting Groups
  Description
Sorafenib Plus Capecitabine (SorCape)

Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.

Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days


Baseline Measures
   Sorafenib Plus Capecitabine (SorCape) 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      29  69.0% 
>=65 years      13  31.0% 
Age 
[Units: Years]
Mean (Full Range)
 57 
 (36 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  21.4% 
Male      33  78.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      42 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      11  26.2% 
White      31  73.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sorafenib Activity   [ Time Frame: 2 years ]

2.  Secondary:   Overall Survival   [ Time Frame: 5 years ]

3.  Secondary:   Toxicity   [ Time Frame: 12 months ]

4.  Secondary:   Response Rate   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

5.  Secondary:   Time to Progression   [ Time Frame: up to 12 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

6.  Secondary:   Correlative Tissue Analysis   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  


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


Results Point of Contact:  
Name/Title: Dr. Thomas J. George, Jr.
Organization: University of Florida
phone: 352-273-8008
e-mail: thom.george@medicine.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01471353     History of Changes
Other Study ID Numbers: ONC2010-23
IRB201701484 ( Other Identifier: University of Florida conversion# )
First Submitted: November 10, 2011
First Posted: November 16, 2011
Results First Submitted: November 15, 2016
Results First Posted: March 30, 2017
Last Update Posted: August 23, 2017