Research Study for Patients With Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

Official Title
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A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: Nexavar (Sorafenib, BAY43-9006)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Life expectancy of at least 12 weeks Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria: History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Nexavar (Sorafenib, BAY43-9006)<br>* Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response Rate (complete and partial response rate) |  | During study treatment or within 30 days after termination of active therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Last date of tumor assessment | 
| Overall response rate |  | Last day of tumor assessement | 
| Time to response |  | throughout study | 
| Safety |  | all visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer