The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.
In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (\>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Disease Control Rate (DCR)
Disease control rate = CR + PR + SD\>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Time frame: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.
Overall Response Rates (OR)
Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Progression-free Survival (PFS)
PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: All patients were followed until progressive disease or death, up to 36 months.
1-year Overall Survival (OS) Rate.
OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.
Time frame: All patients were followed until death or up to 36 months.
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Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Texas Oncology - Arlington South
Arlington, Texas, United States
Texas Oncology, P.A. - Bedford
Bedford, Texas, United States
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
...and 3 more locations
Time to Progression (TTP)
TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: All patients were followed until progressive disease or death, up to 36 months.