Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Cytoreductive Nephrectomy
18 Years
N/A
Both
Renal Cell Carcinoma, Metastatic Disease
Trial Information
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Cytoreductive Nephrectomy
This is a single centre, non-randomized, open label one arm pilot study of Sorafenib 400 mg
twice daily given for 12 weeks preoperatively in patients with advanced metastatic kidney
cancer scheduled for cytoreductive surgery. Patients will be fully staged for disease
progression with Brain MRI, CT, whole body Bone Scans, Kidney ultrasound and biopsy.
Additionally, patients' cardiac status will be evaluated pre-enrolment with an ECG and MUGA
Scan. Once enrolled into the study, patients will have clinic visits on weeks 2, 8 and 12
for monitoring visits with vital signs and adverse event recording plus blood evaluations
for hematology and chemistry. Patients will be called on weeks 3,5,6,7,9,10 and 11 to
determine any changes in health status. Surgery will occur at week 13, after a one week
washout from study drug. Patients will resume on study drug 6 weeks post operatively (or
later, if wound is not completely healed). Patients will continue on study drug and will be
monitored every 4 weeks until disease progression, as determined by bone imaging and CT.
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
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:
To measure primary pathological response data and determine if it relates with time to progression
Outcome Time Frame:
12 weeks- 2 years
Safety Issue:
No
Principal Investigator
Antonio Finelli, MD,MSc,FRCSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Health Canada
Study ID:
06-0655-C
NCT ID:
NCT00480389
Start Date:
May 2007
Completion Date:
January 2012
Related Keywords:
- Renal Cell Carcinoma
- Metastatic Disease
- Clear cell Renal cell carcinoma
- Metastatic
- Sorafenib tosylate
- Preoperative treatment
- Carcinoma
- Carcinoma, Renal Cell
- Neoplasm Metastasis
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