Clinical trial · Interventional
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Kidney Removal
Pre-operative Administration of Sorafenib in Patients With Metastatic Renal Cell Carcinoma Undergoing Cytoreductive Nephrectomy
NCT00480389CI-TRIAL-00020133completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Disease | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- All patients on study will be accrued to this arm. Sorafenib (200 mg tablets x 2) will be administered orally twice a day for 12 weeks (full daily dose of 800 mg). Patient visits for safety will be conducted at least every 4 weeks. Sorafenib dose reductions for drug-related toxicity will be applied based on considerable prior clinical experience. Surgery will be performed at the completion of the 13th week, allowing for a one-week "washout" period. Sorafenib will be continued post operatively (around 6 weeks post surgery or when complete wound healing has occurred) until patient progresses or unacceptable toxicity occurs.
- interventionNames
- Drug: Sorafenib
Primary outcomes (2)
- measure
- To measure primary pathological response data and determine if it relates with time to progression
- timeFrame
- 12 weeks- 2 years
- measure
- Safety of preoperative Sorafenib will be assessed.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDFlanigan RC. Debulking nephrectomy in metastatic renal cancer. Clin Cancer Res. 2004 Sep 15;10(18 Pt 2):6335S-41S. doi: 10.1158/1078-0432.CCR-sup-040026. PMID 15448027
- BACKGROUNDMotzer 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. doi: 10.1200/JCO.1999.17.8.2530. PMID 10561319
- BACKGROUNDFlanigan 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. doi: 10.1056/NEJMoa003013. PMID 11759643
- BACKGROUNDMickisch 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. doi: 10.1016/s0140-6736(01)06103-7. PMID 11583750
- BACKGROUNDEisen et al. Randomized phase III trial of sorafenib in advanced RCC: Impact of crossover on survival. ASCO Atlanta June 2006. Abs 4524