Sorafenib in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Kidney Cancer

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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. Giving sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying the side effects and how well sorafenib works in treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Amgen; Bayer; Doris Duke Charitable Foundation; National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of renal cell carcinoma (RCC) as confirmed by either of the following:

• Radiographic documentation by MRI or CT scan

• Histological evidence of primary RCC

• Stage II-IV disease, as defined by any of the following:

• T > 7 cm

• Renal vein involvement

• Local invasion

• Evidence of lymph node involvement

• Distant metastatic disease

• Deemed suitable for nephrectomy by a urologist

• No requirement for surgery earlier than 4 weeks from study entry

• No known brain metastasis

• Patients with neurological symptoms must undergo a CT scan or brain MRI to exclude brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Hemoglobin ≥ 9.0 g/dL

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)

• Creatinine ≤ 2.5 times ULN or glomerular filtration rate ≥ 50 mL/min

• INR ≤ 1.5 AND PTT normal

• Stable INR required at baseline for patients on warfarin

• Not pregnant or nursing

• Negative pregnancy test

• Fertile women must use effective contraception

• Fertile men must use effective contraception during and for ≥ 2 months after the last dose of sorafenib tosylate

• No other active primary malignancy except skin cancer

• No active coronary artery disease

• No active bleeding diathesis

• Closely monitored therapeutic anticoagulation allowed

• No cardiac disease, including any of the following:

• New York Heart Association class III-IV congestive heart failure

• Unstable angina (i.e., anginal symptoms at rest) or new onset angina (i.e., beginning within the past 3 months)

• Myocardial infarction within the past 6 months

• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management

• No known HIV infection or chronic hepatitis B or C

• No active, clinically serious infection > grade 2

• No thrombolic or embolic events, such as a cerebrovascular accident or transient ischemic attacks, within the past 6 months

• No pulmonary hemorrhage or bleeding event ≥ grade 2 within the past 4 weeks (≥ grade 3 for any nonpulmonary hemorrhage or bleeding event)

• No serious nonhealing wound, ulcer, or bone fracture

• No significant traumatic injury within the past 4 weeks

• No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study

• No condition that impairs the patient's ability to swallow whole pills

• No malabsorption problem

PRIOR CONCURRENT THERAPY:

• No major surgery or open biopsy within the past 4 weeks

• Concurrent anticoagulation therapy (e.g., warfarin or heparin) allowed

• No other concurrent investigational or commercial agents or therapies for RCC

• No concurrent Hypericum perforatum (St. John's wort) or rifampin