Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma
I. Determine the response rate (confirmed and unconfirmed, complete and partial response) of
patients with stage IV uveal melanoma treated with sorafenib, carboplatin, and paclitaxel.
I. Determine the overall and progression-free survival of patients treated with this
II. Determine the toxic effects of this regimen in these patients. III. Determine,
preliminarily, the relationship between clinical outcomes and baseline microvessel density
(MVD) in tumor specimens, changes in vascular endothelial growth factor (VEGF) levels in
plasma and urine, changes in MVD, changes in VEGF receptor-2 phosphorylation in tumor,
and/or changes in ERK 1/2 phosphorylation in stimulated lymphocytes and tumor.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice
daily on days 2-19. Treatment repeats every 21 days for up to 6 courses.* After 6 courses,
patients continue to receive oral sorafenib alone twice daily in the absence of disease
progression or unacceptable toxicity.
[Note: *If sorafenib is discontinued prior to course 6, patients may continue to receive
carboplatin and paclitaxel for up to 6 courses; if carboplatin and paclitaxel are
discontinued prior to course 6, patients may continue to receive sorafenib alone twice daily
on days 1-21 of each course in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Complete and Partial Response)
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression
Southwest Oncology Group
United States: Food and Drug Administration
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