Carcinoma, Renal Cell
Conditions
Keywords
Cancer
Brief summary
This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.
Interventions
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.
DRUGPlacebo
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)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Overall Response Rate (complete and partial response rate) | During study treatment or within 30 days after termination of active therapy |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed