Clinical Research Details
Title:
Mechanistic Evaluations of Sorafenib-induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma (RCC)
Purpose:
The purpose of this study is to better understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The effect of sorafenib treatment on the heart’s ability to pump blood efficiently also will be studied.
Study Number:
202081081909
Number of Patients:
60
Elgibility:
Screening must be done within 28 days before study drug administration. All patients must meet the following criteria at screening, unless otherwise specified:
Age = 18 years with histologically or cytologically confirmed advanced RCC
Evaluable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques (i.e., PE, CT, XR, MRI) or as =10 mm with spiral CT scan. Tumor measurements must be recorded in millimeters (or decimal fractions of centimeters) according to the modified Response Evaluation Criteria in Solid Tumors (RECIST).
ECOG Performance Status of 0 or 1
Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within seven days prior to screening:
Labs values as follows: Hemoglobin > 9.0 g/dL, absolute neutrophil count (ANC) > 1,500/mm3, platelet count ? 100,000/mm3, total bilirubin = 1.5 times the upper limit of normal, ALT and AST = 2.5 x upper limit of normal (= 5 x upper limit of normal for patients with liver involvement of their cancer), amylase and lipase < 1.5 x the upper limit of normal, PT-INR/PTT ? 1.5 x ULN, creatinine < 2.0 x the upper limit of normal and phosphate ? 2.0 mg/dl.
LVEF = 40%
Women of childbearing potential must have a negative serum pregnancy test performed within seven days prior to the start of treatment. Negative results must be available prior to study treatment.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30-day period after last study drug dosing. The investigator should advise the patient how to achieve adequate contraception.
Treatment:
If the above tests show that you are eligible, you will come to the clinic in the morning of Cycle 1, Day 1.
All patients in this study will be treated with 400 mg sorafenib (two-200 mg oral tablets), twice a day on a continuous basis. This is the dose schedule approved by the FDA for treatment of renal cell cancer. Treatment will follow a 4-week (28 day) schedule, and each 4-week period is known as a “cycle.” The first time you receive sorafenib, you will be in the clinic. When you leave the clinic, and for the rest of the time you are in the study, you will be given enough sorafenib tablets to take on your own at home until your next scheduled clinic visit.
Principal Investigator:
Enrollment Phone:
(708) 327-3221