Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
This trial is active, not recruiting.
|Treatments||sorafenib tosylate, flow cytometry, laboratory biomarker analysis|
|Targets||RAF, FLT-3, KIT, PDGF, VEGF|
|Sponsor||University of Nebraska|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2007|
|End date||October 2009|
|Trial size||14 participants|
|Trial identifier||NCT00496756, 081-06, P30CA036727, UNMC-08106|
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Toxicity of intrapatient dose escalation of sorafenib tosylate
time frame: Study completion
time frame: from the start of the treatment until disease progression/recurrence
Time to progression
time frame: from the start of study treatment to disease progression or death
time frame: From start of study treatment until death
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed renal cell carcinoma (RCC) - Must have a component of conventional clear cell RCC - Predominant clear cell component ≥ 75% - Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible - Metastatic or unresectable disease - Measurable or nonmeasurable disease - Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI - Nonmeasurable disease includes any of the following: - Small lesions with longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonitis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Irradiated lesions, unless progression is documented after radiotherapy - Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF - No evidence of CNS metastases - No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within the past 42 days PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception (hormonal and/or barrier method) during and for 3 months after completion of study treatment - Granulocyte count ≥ 1,500/µL - Platelet count ≥ 100,000/µL - AST/ALT ≤ 2.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - Serum bilirubin ≤ 1.5 times ULN - Protein ≤ 1+ by urinalysis - Creatinine ≤ 1.5 times ULN - No ongoing hemoptysis - No cerebrovascular accident within the past 12 months - No peripheral vascular disease with claudication while walking less than 1 block - No history of clinically significant bleeding - No deep venous thrombosis or pulmonary embolus within the past year - No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months - No uncontrolled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication - No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication - No uncontrolled psychiatric disorder - No delayed healing of wounds, ulcers, and/or bone fractures - No currently active second malignancy except nonmelanoma skin cancer - Patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior major surgery and/or radiotherapy and recovered - No more than one prior systemic therapy for RCC - No prior vascular endothelial growth factor receptor agents - Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated - More than 4 weeks since prior and no other concurrent anticancer therapy - Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis - No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency) - Topical and/or inhaled steroids allowed - No concurrent full-dose oral or parenteral anticoagulation - Low-dose warfarin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin allowed - No concurrent Hypericum perforatum (St. John's wort) - No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing grapefruit juice - No concurrent hormonal therapy or chemotherapy - Concurrent hormones administered for non-disease related conditions (e.g., insulin for diabetes) allowed
|Official title||A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma|
|Principal investigator||Ralph Hauke, MD|
|Description||OBJECTIVES: Primary - Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma. Secondary - Determine tumor response in these patients. - Determine time to progression in these patients. - Determine overall survival of these patients. Tertiary - Collect data on angiogenesis inhibition induced by sorafenib tosylate. - Collect data on immunomodulatory effects of sorafenib tosylate. OUTLINE: This is an open-label study. Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4 dose-limiting toxicity) until a pre-determined dose is reached. Blood and urine samples are collected at baseline and periodically during study for VEGF level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF.|
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