A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY 43-9006 (Sorafenib) in Metastatic Renal Cell Carcinoma
I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities
of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and
peri/postoperative safety of BAY 43-9006.
I. Time to progression. II. Duration of response. II. Overall Survival.
I. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR,
ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, P27, Ki67,
TGF-alpha, and TUNEL pre- and post- therapy (optional studies).
II. Oligonucleotide analysis of tissue pre- and post-therapy (optional studies).
OUTLINE: This is a non-randomized study. Patients are sequentially assigned to 1 of 3
GROUP I: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral
sorafenib twice daily on days 15-84.
GROUP II: Patients receive oral sorafenib twice daily on days 1-7. Patients undergo
cytoreductive nephrectomy on day 8. Patients then receive oral sorafenib twice daily on days
GROUP III: Patients receive oral sorafenib twice daily on days 1-28. Patients undergo
cytoreductive nephrectomy on day 29. Patients then receive oral sorafenib twice daily on
In all groups, patients with stable or regressing disease continue to receive oral sorafenib
twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Some patients may continue treatment for longer than 1 year at the discretion of the
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment group) will be accrued for this
study within 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of BAY 43-9006 by Evaluating Response Rate
Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
Every 2 weeks during 4 week cycle
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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