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

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

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

Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib
may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is
with minimal toxicity, presents an opportunity to explore a more intensive drug
administration. This study will allow individual patient titration (e,g,, intrapatient dose
escalation) as per protocol.

This provides the basis for the dose escalation development of sorafenib. The study is
designed to evaluate the ability for patients to dose escalate. Secondary endpoints include;
response, time to progression, and overall survival in patients with MRCC. Tissue
correlation to evaluate the impact of expression of receptor on clinical outcome will be
retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated
and evaluated to clinical outcome.

Inclusion Criteria:

- Histologically or cytological confirmed metastatic or unresectable clear cell renal
cell carcinoma.

- No more than one prior systemic therapy. No prior vascular endothelial growth factor
receptor agents.

- Patients with primary tumor in place are strongly encouraged to undergo nephrectomy
prior to initiation of study agent.

- Prior palliative radiotherapy to metastatic lesion(s) is permitted.

- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks
prior to registration.

- Patients must have metastatic or unresectable disease.

- Paraffin RCC tissue blocks or unstained slides must be available.

- Karnofsky performance status > 70 % .

- Not pregnant

- Age > 18

- Must meet required initial laboratory values

Exclusion Criteria:

- No ongoing hemoptysis, or cerebrovascular accident within 12 months, or peripheral
vascular disease with claudication on less than 1 block, or history of clinically
significant bleeding.

- No deep vein thrombosis or pulmonary embolus within one year of study enrollment and
no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin
(1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.

- No evidence of current central nervous system (CNS) metastasis. All patients must
undergo an MRI or CT scan of the brain (with contrast, if possible) within 42 days
prior to registration. Any imaging abnormality indicative of CNS metastases will
exclude the patient from the study.

- No significant cardiovascular disease defined as congestive heart failure (New York
Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or
recent myocardial infarction (within the last 6 months).

- No patients with uncontrolled hypertension (defined as blood pressure of >160 mmHg
systolic and/or > 90 mmHg diastolic on medication).

- Any ongoing requirement for systemic corticosteroid therapy is not permitted. Topical
and/or inhaled steroids are allowed.

- No pre-existing thyroid abnormality whose thyroid function cannot be maintained in
the normal range by medication are ineligible.

- No uncontrolled psychiatric disorder.

- Patients with delayed healing of wounds, ulcers and/or bone fractures are not

- Patients with a 'currently active' second malignancy other than non-melanoma skin
cancers are not eligible. Patients are not considered to have a 'currently active'
malignancy if they have completed anti-cancer therapy and are considered by their
physician to be a less than 30% risk of relapse.

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:

Tumor progression rate by RECIST criteria

Outcome Time Frame:

restaging every 8 weeks

Safety Issue:


Principal Investigator

Robert J Amato, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

October 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Metastatic Renal Cell Carcinoma
  • Metastatic RCC
  • Kidney Cancer
  • M3thodist
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



The Methodist Hospital Research Institute Houston, Texas  77030