Status:
TERMINATED
Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hereditary Clear Cell Renal Cell Carcinoma
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief 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 tum...
Detailed Description
OBJECTIVES: Primary * To demonstrate the feasibility and safety of sorafenib tosylate when given prior to nephrectomy or metastasectomy. * To evaluate the ability of diffusion-weighted magnetic reso...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria:
- Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 \> 3 cm, any T2, T3, or T4) appropriate for nephrectomy
- Limited metastatic disease, as evidenced by any renal primary (T1 \> 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy
- Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size \> 2 cm) appropriate for metastasectomy
- No known brain metastasis
- Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group performance status 0-1
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement)
- Creatinine ≤ 1.5 times ULN
- Estimated glomerular filtration rate \> 30 mL/min (for patients receiving Gd-enhanced MRI)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy
- Adequate cardiac and pulmonary status for operative therapy
- No active clinically serious infection \> CTCAE grade 2
- No known HIV, hepatitis B, or hepatitis C infections
- No serious non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 4 weeks
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- No history of an uncontrolled bleeding disorder including, but not limited to, any of the following:
- Bleeding diathesis
- Coagulopathy
- No cardiac disease or condition including, but not limited to, any of the following:
- New York Heart Association class II-IV congestive heart failure
- Unstable angina (anginal symptoms at rest)
- New onset angina beginning within the last 3 months
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
- No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks)
- No condition that impairs the ability to swallow whole pills
- No malabsorption problem
- No contraindication to MRI, including, but not limited to, any of the following:
- Ferromagnetic implants
- Dental work
- Pacemakers
- Metallic implants
- Severe claustrophobia which precludes closed MRI testing
- No known or suspected allergy to sorafenib tosylate
- No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis)
- No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior major surgery or open biopsy
- No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab)
- No concurrent Hypericum perforatum (St. John's wort) or rifampin
- No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00727532
Start Date
July 1 2008
End Date
September 1 2013
Last Update
May 3 2019
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013