Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sorafenib is more effective than a placebo in treating kidney cancer. PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works compared with a placebo in treating patients at risk of relapse after undergoing surgery to remove kidney cancer.

Detailed Description
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OBJECTIVES: Compare disease-free survival of patients with resected primary renal cell carcinoma at high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years. OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral placebo twice daily for 2 years in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the absence of disease progression or unacceptable toxicity. Patients in arms I and II with progressive disease may cross over and receive treatment in arm III. After completion of study treatment, patients are followed periodically.

Official Title
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SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: sorafenib tosylate
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma (RCC) Clear cell or non-clear cell tumors allowed Intermediate- or high-risk disease (Leibovich score 3 to 11) Must have undergone surgery for RCC at least 4 weeks but no more than 3 months prior to study entry No evidence of residual macroscopic disease on post-operative CT scan after resection of RCC PATIENT CHARACTERISTICS: WHO performance status 0-1 WBC > 3,400/mm³ Platelet count > 99,000/mm³ Creatinine < 2.5 times upper limit of normal (ULN) Liver function tests < 1.5 times ULN Serum amylase < 1.5 times ULN PT/INR < 1.5 times ULN PTT < 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 9 months after completion of study treatment No cardiovascular conditions, including any of the following: Cardiac arrhythmias requiring anti-arrhythmic medication Beta-blockers and digoxin allowed Symptomatic coronary artery disease or ischemia Myocardial infarction within the past 6 months NYHA class II-IV congestive heart failure No active clinically serious bacterial or fungal infection No known history of HIV infection No chronic hepatitis B or C No other prior malignancy except carcinoma in situ of the cervix or adequately treated basal cell carcinoma No uncontrolled hypertension PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior treatment for RCC other than nephrectomy More than 30 days since prior and no other concurrent investigational therapy No concurrent medications that have adverse interactions with sorafenib tosylate including, but not limited to, any of the following: Rifampin Grapefruit juice Ritonavir Ketoconazole Itraconazole Hypericum perforatum (St John's wort) No concurrent bone marrow transplant or stem cell rescue No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors (e.g., bevacizumab) No other concurrent drug that targets Ras-pathway or EGFR No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal transduction inhibition, or hormonal therapy) Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or mineral supplements allowed Concurrent bisphosphonates for prophylaxis of osteoporosis allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sorafenib tosylate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastasis-free survival |  |  | 
| Disease-specific survival time |  |  | 
| Overall survival |  |  | 
| Cost effectiveness |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer, stage I renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma