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A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma



- Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with
metastatic or unresectable renal cell carcinoma.


- Determine tumor response in these patients.

- Determine time to progression in these patients.

- Determine overall survival of these patients.


- Collect data on angiogenesis inhibition induced by sorafenib tosylate.

- Collect data on immunomodulatory effects of sorafenib tosylate.

OUTLINE: This is an open-label study.

Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4
weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4
dose-limiting toxicity) until a pre-determined dose is reached.

Blood and urine samples are collected at baseline and periodically during study for VEGF
level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow
cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of

Inclusion Criteria


- Histologically or cytologically confirmed renal cell carcinoma (RCC)

- Must have a component of conventional clear cell RCC

- Predominant clear cell component ≥ 75%

- Patients with true papillary, sarcomatoid features without any clear cell
component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell
carcinoma are not eligible

- Metastatic or unresectable disease

- Measurable or nonmeasurable disease

- Measurable disease is defined as any lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) as ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan or MRI

- Nonmeasurable disease includes any of the following:

- Small lesions with longest diameter < 20 mm by conventional techniques or <
10 mm by spiral CT scan

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonitis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Irradiated lesions, unless progression is documented after radiotherapy

- Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry
staining of VEGF

- No evidence of CNS metastases

- No imaging (MRI or CT scan of the brain) abnormality indicative of CNS
metastases within the past 42 days


- Karnofsky performance status 70-100%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception (hormonal and/or barrier method)
during and for 3 months after completion of study treatment

- Granulocyte count ≥ 1,500/µL

- Platelet count ≥ 100,000/µL

- AST/ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Serum bilirubin ≤ 1.5 times ULN

- Protein ≤ 1+ by urinalysis

- Creatinine ≤ 1.5 times ULN

- No ongoing hemoptysis

- No cerebrovascular accident within the past 12 months

- No peripheral vascular disease with claudication while walking less than 1 block

- No history of clinically significant bleeding

- No deep venous thrombosis or pulmonary embolus within the past year

- No significant cardiovascular disease, defined as NYHA class II-IV congestive heart
failure, angina pectoris requiring nitrate therapy, or myocardial infarction within
the past 6 months

- No uncontrolled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP
> 90 mm Hg while on medication

- No preexisting thyroid abnormality whose thyroid function cannot be maintained in the
normal range by medication

- No uncontrolled psychiatric disorder

- No delayed healing of wounds, ulcers, and/or bone fractures

- No currently active second malignancy except nonmelanoma skin cancer

- Patients are not considered to have a 'currently active' malignancy if they have
completed anticancer therapy and are considered by their physician to be at less
than 30% risk of relapse


- At least 4 weeks since prior major surgery and/or radiotherapy and recovered

- No more than one prior systemic therapy for RCC

- No prior vascular endothelial growth factor receptor agents

- Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at
least one measurable and/or evaluable lesion(s) that has not been irradiated

- More than 4 weeks since prior and no other concurrent anticancer therapy

- Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis

- No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal

- Topical and/or inhaled steroids allowed

- No concurrent full-dose oral or parenteral anticoagulation

- Low-dose warfarin (1 mg) for maintenance of catheter patency or daily
prophylactic aspirin allowed

- No concurrent Hypericum perforatum (St. John's wort)

- No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing
grapefruit juice

- No concurrent hormonal therapy or chemotherapy

- Concurrent hormones administered for non-disease related conditions (e.g.,
insulin for diabetes) allowed

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity of intrapatient dose escalation of sorafenib tosylate

Outcome Description:

To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.

Outcome Time Frame:

Study completion

Safety Issue:


Principal Investigator

Ralph Hauke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

January 2015

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680