Status:
COMPLETED
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Lead Sponsor:
Stanford University
Conditions:
Carcinoma, Renal Cell
Kidney Disease
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
Detailed Description
Sorafenib to be administered as 28-day cycles. Sorafenib dose escalation by cycle is: * Cycle 1: 400 mg BID * Cycle 2: 600 mg BID * Cycle 3+: 800 mg BID Within subject dose escalation and maximum d...
Eligibility Criteria
Inclusion
- Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
- must have a component of conventional clear cell renal carcinoma.
- No more than one prior systemic therapy.
- No prior vascular endothelial growth factor receptor agents.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.
- Measureable disease by RECIST criteria
- Karnofsky performance status at least 70% or ECOG not more than 2
- Ability to give written informed consent
- At least 18 years old
- Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
- Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
- ANC at least 1,500/uL
- Platelet count at least 100,000/uL
- AST/ALT not more than 2.5 times the upper limit of normal (ULN)
- Alkaline phosphatase not more than 2.5 x ULN
- Serum bilirubin not more than 1.5 x ULN
- Amylase/Lipase within normal range
- Urinalysis not more than 1+ protein
- Serum creatinine not more than 1.5 x ULN
- No active ischemia by ECG
- Echocardiogram or MUGA ejection fraction at least 40%
Exclusion
- Ongoing hemoptysis
- Cerebrovascular accident within 12 months
- Peripheral vascular disease with claudication on less than 1 block
- History of clinically significant bleeding
- Malignancy with true papillary/sarcomatoid features without any clear cell component
- Chromophobe
- Oncocytoma
- Collecting duct tumors
- Transitional cell carcinoma
- Deep venous thrombosis or pulmonary embolus within one year of consent
- Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed
- Subjects with evidence of current central nervous system (CNS) metastases
- MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
- Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
- Angina pectoris requiring nitrate therapy
- Myocardial infarction within the last 6 months
- Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
- Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
- Uncontrolled psychiatric disorder
- Delayed healing of wounds, ulcers, and/or bone fractures
- Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed \> 5 years ago and from which the patient has been disease-free for \> 5 years)
- Pregnant
- Currently lactating
- Currently using St John's Wort (an herb)
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00854620
Start Date
December 1 2007
End Date
January 1 2011
Last Update
June 19 2015
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305