Melanoma Clinical Trial
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
Eligibility Criteria
Inclusion Criteria:
Patients who have a life expectancy of at least 12 weeks
Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
Patients who have an ECOG PS of 0, or 1
Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion Criteria:
Primary ocular or mucosal melanoma
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 3 years prior to study entry
History of cardiac disease
Known history of human immunodeficiency virus (HIV) infection
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There are 14 Locations for this study
Tucson Arizona, 85724, United States
Aurora Colorado, 80045, United States
Lakeland Florida, 33805, United States
Park Ridge Illinois, 60068, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
St. Louis Missouri, 63110, United States
Omaha Nebraska, 68114, United States
Charlotte North Carolina, 28203, United States
Pittsburgh Pennsylvania, 15232, United States
Hilton Head Island South Carolina, 29926, United States
Nashville Tennessee, 37232, United States
San Antonio Texas, 78229, United States
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