The purpose of this study is to evaluate the good and bad effects when regorafenib is used instead of standard combination chemotherapy. It is not known if taking regorafenib versus standard chemotherapy will have better, worse or the same results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
All patients that meet the eligibility criteria who have signed informed consent and have enrolled on the trial will be treated with regorafenib, daily 3 weeks on 1 week off for all cycles. Dose will be escalated to 120 mg in week 2 of cycle 1 and all remaining cycles if no excess toxicity is experienced by the patient at the discretion of the treating physician.
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Downstate Medical Center
Brooklyn, New York, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Queens Cancer Center of Queens Hospital
progression free survival
Response and progression will be evaluated in this study using the international criteria proposed by the RECIST 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
Time frame: 16 weeks
overall survival
Overall survival is defined as the time from treatment start to death or last follow up. Survival will be estimated using the Kaplan-Meier method.
Time frame: 2 years
disease control rate
Disease control rate (defined with RECIST 1.1 criteria at 16 weeks (2nd scan) as CR, PR or SD), will be estimated using proportions and exact binomial 95% confidence intervals provided.
Time frame: 16 weeks
duration of stable disease
Duration of stable disease will be defined as the time from stable disease to the time of documented progression.
Time frame: 2 years
toxicity
will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0. The assessments will be based on recorded adverse events, physical examinations, and clinical laboratory assessments. Toxicity will be summarized using descriptive statistics.
Time frame: 2 years
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Jamaica, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
Memorial Sloan Kettering Cancer Center Sleepy Hollow
Sleepy Hollow, New York, United States