Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer
Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal cancer may provide clinical benefit when no other treatment remains.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer|
- Sorafenib activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Evaluate overall survival after treatment.
- Progression free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]Evaluate progression free survival at 3 months after treatment
- Response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]Measure response rate to treatment
- Time to progression [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]Time to disease progression while on and/or after treatment complete
- Toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Evaluate acute toxicity of treatment
- Correlative tissue analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]Exploratory tissue analysis in patients receiving sorafenib plus capecitabine
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Single arm study
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
The Raf/MEK/ERK pathway is an important mediator of responses to growth factors, and a strong inducer of genes involved in tumorigenesis, angiogenesis, apoptosis, and tumorigenesis in metastatic colorectal cancer (mCRC). Inhibition of this pathway has been previously proven to be highly clinically beneficial for patients with this disease. It has also been clearly demonstrated that the inhibition of VEGF, when coupled with cytotoxic therapy and/or continued beyond initial response, can improve clinical outcomes and survival in this same cohort of patients. Safety and pharmacokinetic data have already been established for this novel doublet oral chemotherapy. This study is intended to determine the activity of a combination of oral fluoropyrimidine plus sorafenib in an advanced mCRC patient population for whom limited treatment options remain.
|Contact: Alison Ivey, RN||352-265-0680 ext email@example.com|
|Contact: Joanna Scian, MPH||352-265-0680 ext firstname.lastname@example.org|
|United States, Florida|
|University of Florida Shands Cancer Center||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Alison Ivey, RN 352-265-0680 ext 88411 email@example.com|
|Principal Investigator:||Thomas George, MD, FACP||University of Florida|