This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.
All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
5-mg tablets PO BID
5 mg/kg Days 1 and 15; IV
400 mg/m2 Days 1 and 15; IV
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists-South
Fort Myers, Florida, United States
Woodlands Medical Specialists
Pensacola, Florida, United States
Progression-free Survival
Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Time frame: 24 months
Objective Response Rate
Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.
Time frame: every 8 weeks, assessed up to approximately 24 months
Time To Progression (TTP)
Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.
Time frame: every 8 weeks, assessed approximately up to 24 months
Overall Survival (OS)
Defined as the time from first treatment until death from any cause.
Time frame: every 8 weeks until progression then every 3 months for up to 5 years.
Frequency of Adverse Events as a Measure of Safety
The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
Time frame: Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.
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2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous
400 mg/m2 Days 1 and 15; IV
85 mg/m2 Days 1 and 15; IV
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Oncology Hematology of SW Indiana
Newburgh, Indiana, United States
Hope Cancer Center
Terre Haute, Indiana, United States
Grand Rapids Oncology Program
Grand Rapids, Michigan, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Atlantic Health System
Summit, New Jersey, United States
...and 2 more locations