Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer

Status: Terminated
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2

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.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No

• 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.

United States
North Carolina
Duke University Medical Center
Time Frame
Start Date: March 2008
Completion Date: September 2009
Target number of participants: 1
Collaborators: Bayer
Leads: Duke University

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