Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer (SorCape)
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|ClinicalTrials.gov Identifier: NCT01471353|
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : March 30, 2017
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: Sorafenib Plus Capecitabine (SorCape)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||May 2017|
Experimental: 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.
Drug: 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
- Sorafenib Activity [ Time Frame: 2 years ]Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Overall Survival [ Time Frame: 5 years ]Evaluate overall survival after treatment.
- Response Rate [ Time Frame: 3 months ]This is the percentage of subjects that achieved either a complete response or a partial response per RECIST 1.1 criteria
- Response Duration [ Time Frame: up to 12 months ]This is the median response duration (median time from date of a complete or partial response to date of disease progression per RECIST 1.1 criteria) and includes only subjects that achieved either a complete or partial response to treatment per RECIST 1.1 criteria.
- Toxicity (Percentage of Subjects That Experienced an Adverse Event) [ Time Frame: 12 months ]Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system - a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.
- Correlative Tissue Analysis [ Time Frame: 6 months ]Exploratory tissue analysis in patients receiving sorafenib plus capecitabine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471353
|United States, Florida|
|UF Health Cancer Center|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Thomas George, MD, FACP||University of Florida|