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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


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Overall Complete and Partial Response (CR+PR)

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

John Kirkpatrick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00001398

NCT ID:

NCT00672178

Start Date:

March 2008

Completion Date:

September 2009

Related Keywords:

  • Renal Cell Carcinoma
  • RCC
  • metastatic
  • sorafenib
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Duke University Medical CenterDurham, North Carolina  27710