This trial is active, not recruiting.

Condition kidney cancer
Treatments sorafenib tosylate, flow cytometry, laboratory biomarker analysis
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
sorafenib tosylate
initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg
flow cytometry
15 ml of blood drawn for flow cytometry of T4/T8, NK, CD25+, and Fox p3 testing obtained at baseline and on days 28, 56, 84, and 112
laboratory biomarker analysis
15 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained at baseline.10 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained on days 28, 56, 84 and 112

Primary Outcomes

Toxicity of intrapatient dose escalation of sorafenib tosylate
time frame: Study completion

Secondary Outcomes

Response Rate
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
Overall survival
time frame: From start of study treatment until death

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Nebraska.