At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic or unresectable melanoma from cutaneous, mucosal, or unknown primary site
- ✓No prior systemic cytotoxic chemotherapy (with exception of isolated limb perfusion); may have received prior immunotherapy or one prior investigational agent (not chemotherapy or Ras/Raf/MEK inhibitor)
- ✓ECOG performance status 0 or 1
- ✓Measurable disease by RECIST; all disease sites evaluated within 4 weeks of registration
- ✕Ocular melanoma
- ✕History or clinical evidence of brain metastases; head MRI required within 4 weeks before enrollment
- ✕Other current malignancies except basal or squamous cell skin cancer, in situ cervical cancer, or DCIS/LCIS of breast; other malignancies allowed if disease-free ≥5 years
- ✕Evidence of bleeding diathesis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
In Brief
A Phase 3 clinical trial evaluating Carboplatin, Laboratory Biomarker Analysis, and 4 other interventions for Mucosal Melanoma and 5 related conditions. Completed, enrolled 823 participants across 219 sites in 2 countries.
Detailed Summary
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
Study Details
Timeline
Interventions
Given IV
Correlative studies
Given IV
Correlative studies
Given PO
Given PO