Renal Cell Carcinoma Clinical Trial
Official title:
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Cytoreductive Nephrectomy
Verified date | December 2015 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to see if preoperative administration of Sorafenib reduces the
size of the primary kidney tumour in patients with metastatic disease undergoing
cytoreductive surgery.
The study will also assess the safety of preoperative Sorafenib.
The study drug, Sorafenib, will be given to patients preoperatively for 12 weeks. After a 1
week washout period the patient will then have their nephrectomy (kidney removed).
Approximately 6 weeks following their nephrectomy, patients will resume on study drug until
disease progression.
Status | Completed |
Enrollment | 19 |
Est. completion date | March 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Bayer |
Canada,
Eisen et al. Randomized phase III trial of sorafenib in advanced RCC: Impact of crossover on survival. ASCO Atlanta June 2006. Abs 4524
Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. — View Citation
Flanigan RC. Debulking nephrectomy in metastatic renal cancer. Clin Cancer Res. 2004 Sep 15;10(18 Pt 2):6335S-41S. Review. — View Citation
Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. — View Citation
Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure primary pathological response data and determine if it relates with time to progression | 12 weeks- 2 years | No | |
Primary | Safety of preoperative Sorafenib will be assessed. | 13 weeks | Yes | |
Secondary | Tumour vascularity. | 12 weeks | No | |
Secondary | Immunohistochemistry will be used to assess the effects of Sorafenib on angiogenic and tumorigenic promoters. Signals from VEGFR2, PDGF-alpha, c-KIT, Flt-3, CAIX and Raf-1 will be assessed. | 13 weeks | No | |
Secondary | A DNA microarray will be used for gene expression profiling of the tissue harvested at biopsy and surgery. | 13 weeks | No |
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