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A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

Phase 2
18 Years
Open (Enrolling)
Renal Cell Cancer

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Trial Information

A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer
and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts
of the body is one of the most treatment-resistant diseases. Standard of care treatment
usually involves chemotherapy. Results from chemotherapy have been disappointing.
Therefore, there is a need to develop additional safe and effective therapies to treat
advanced kidney cancer.

Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney
cancer. Sorafenib works by interfering with a type of protein in your body that determines
how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills)
twice/day, given seven days/week, may slow progression of the disease for an average of
three months but it is not expected to be curative. Preliminary studies have suggested
higher doses of sorafenib may increase the chance that the tumor will shrink.

Inclusion Criteria

Inclusion Criteria

- Age ≥ 18 years old.

- ECOG Performance Status 0, 1 or 2.

- 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 ULN

- and AST ≤ 2.5 times the ULN (≤ 5 x ULN for patients with liver involvement)

- Creatinine < 1.5 times ULN

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to of treatment.

- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study.
Men should use adequate birth control for at least three months after the last
administration of sorafenib.

- Ability to understand and willing to sign written informed consent. A signed
informed consent must be obtained prior to any study specific procedures.

- INR < 1.5 or a PT/PTT within normal limits unless receiving anti-coagulation
treatment with an agent such as warfarin or heparin. These patients may be allowed to
participate. For patients on warfarin, the INR should be measured prior to
initiation of sorafenib and monitored at least weekly, or as defined by the local
standard of care, until INR is stable.

- Must have histologically or cytologically confirmed renal cell carcinoma that is
metastatic (M1). Patients with unresectable primary tumor (but MO) are also

- Must have measurable disease, defined as at least 1 lesion that can be accurately
measured in at least 1 dimension. Soft tissue disease that has been radiated in the
2 months prior to registration is not assessable as measurable disease. Soft tissue
disease within a prior radiation field must have progressed to be considered
assessable. X-rays, scans or physical examinations used for tumor measurement must
have been completed within 28 days prior to registration. X-rays, scans or physical
examinations for non-measurable disease must have been completed within 42 days prior
to registration.

- Patients with metastatic disease who have a resectable primary tumor and are deemed a
surgical candidate may have undergone resection and have recovered from surgery. At
least 28 days must have elapsed since surgery and must have recovered from any
adverse effects of surgery.

- May have received 1 prior immunotherapy with either interferon (IFN) and/or
Interleukin-2 (IL-2) or the combination of IFN/IL2 and only 1 prior biologic agent
(sunitinib, bevacizumab, or temsorlimus). Must have progressed during this prior
therapy. At least 14 days must have elapsed since the last treatment and must have
recovered from any adverse effects of prior therapy. May have received prior
radiation therapy. At least 21 days must have elapsed since completion of prior
radiation therapy. Must have recovered from all associated toxicities at the time of

Exclusion Criteria

- Cardiac disease: Congestive heart failure > class II NYHA. Must not have unstable
angina (anginal symptoms at rest) or new onset angina (began within the last 3
months) or myocardial infarction within past 6 months.

- Known brain metastasis. Patients with neurological symptoms must undergo a CT
scan/MRI of the brain to exclude brain metastasis.

- Patients who have received prior sorafenib are ineligible.

- 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/C.

- Active clinically serious infection > CTCAE Grade 2.

- Thrombosis or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months. Patients with renal or caval thrombosis
related to the primary renal tumor would not be excluded and are eligible.

- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of
study drug.

- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of
study drug.

- Serious non-healing wound, ulcer, or bone fracture.

- Evidence or history of bleeding diathesis or coagulopathy.

- 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

- Any condition that impairs patient's ability to swallow whole pills.

- Any malabsorption problem.

Type of Study:


Study Design:

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

Outcome Measure:

Patient safety and drug tolerance

Outcome Description:

Primary outcome is the evaluation of toxicity and tolerability of this dose escalation schedule.

Outcome Time Frame:

June 2011

Safety Issue:


Principal Investigator

Peter J Van Veldhuizen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

June 2015

Related Keywords:

  • Renal Cell Cancer
  • carcinoma, renal cell
  • kidney
  • cancer
  • Carcinoma, Renal Cell



University of Kansas Medical Center Kansas City, Kansas  66160-7353