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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00672178
• Other study ID #: Pro00001398
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 4, 2008
• Last updated: January 9, 2011
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In the phase I portion of this investigation, subjects will be enrolled in cohorts of three to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks post-therapy for toxicity.

Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort until the maximum tolerated dose of radiation is determined.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Radiation:
• Stereotactic body radiation
Stereotactic body radiotherapy will be given in three cohorts of increasingly higher dose levels: Cohort 1: 6 Gy/fraction x 3 fractions (total=18 Gy) over 5 days; Cohort 2: 8 Gy/fraction x 3 fractions over 5 days; Cohort 3: 10 Gy/fraction x 3 fractions over 5 days.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Overall Complete and Partial Response (CR+PR)		8 weeks	No