Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Kidney Removal

Plain-language summary

This study looks at Sorafenib given before surgery in patients with metastatic renal cell carcinoma who are scheduled to have a kidney removed (nephrectomy). Patients with biopsy-proven clear cell kidney cancer that had spread were able to take part. Sponsored by the University Health Network, Toronto, the study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

University Health Network, Toronto

Intervention

Sorafenib

Start date

5/1/2007

Estimated completion

3/1/2013

Countries

Canada

Related genes

Locations

• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Biopsy proven RCC with a component of clear cell type histology
* Patients must have confirmed metastatic disease
* Candidate for cytoreductive nephrectomy
* Adequate organ function as defined by:

  * AST or ALT less than or equal to 2.5 times the upper limit of normal
  * Bilirubin less than or equal to 1.5 times the upper limit of normal
  * Absolute neutrophil count (ANC) greater than or equal to 1500/mL
  * Platelets greater than or equal to 100,000/mL
  * Hemoglobin greater than or equal to 9.0 g/dL
  * Serum calcium less than or equal to 12.0 mg/dL
  * Serum creatinine less than or equal to 1.5 x CL-ULN
* Male or female, 18 years of age or older
* Women of childbearing potential must NOT be pregnant (as confirmed by a negative pregnancy test)
* ECOG performance status 0 or 1 (see appendix 1 for ECOG performance status)
* Signed informed consent form indicating that the patient or acceptable representative has been informed of all parts of the trial prior to enrollment
* Willingness and ability to comply with study procedures

Exclusion Criteria:

* Presence of brain metastases during screening period
* Known hypersensitivity to Sorafenib
* Women who are breast-feeding
* Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator
* History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
* HIV-positive patients