Stereotactic Body Radiotherapy (SBRT) and Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer (RCC)

Stopped early · Phase 1/Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.

Key facts

Study ID

NCT00672178

Run by

Duke University

People needed

1

Starts

2008-03-01

Expected to finish

2009-09-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years old
• Zubrod Performance Status 0 or 1
• Adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin > 9.0 g/dl
• Absolute neutrophil count (ANC) > 1,500/mm3
• Platelet count > 100,000/mm3
• Total bilirubin < 1.5 times institutional upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the institutional ULN
• Creatinine < 1.5 times institutional ULN
• Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.
• Life expectancy > 6 months
• Local recurrence or progression of primary lesion or progression, or symptomatic progression in extra-cranial, extra-pulmonary metastases while on sorafenib
• Measurable disease
• Bone metastases must have a tissue component measurable by imaging.
• No untreated brain metastases
• Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste alteration.
• Willingness and ability to comply with continuing sorafenib, visits, treatment plans, laboratory tests and study procedures.
• All treated lesions must comply with SBRT dose constraints
• More than 28 days since any prior systemic or local therapy for this cancer, including investigational agents and surgical procedures exclusive of sorafenib
• Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control)
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
• Ability to understand and the willingness to sign a written informed consent.
• Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.

You may not qualify if…

• Lesion in remaining (solo) kidney
• Contraindications to radiotherapy or prior radiotherapy overlapping current site(s) of disease.
• Cardiac disease: Congestive heart failure. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Active clinically serious infection
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding problems
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Use of St. John's Wort or rifampin (rifampicin).
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• Any condition that impairs patient's ability to swallow whole pills.
• Any malabsorption problem.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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