Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma
About this trial
This is an interventional treatment trial for Ciliary Body and Choroid Melanoma, Medium/Large Size
Eligibility Criteria
Criteria: Histologically proven uveal melanoma Must have documented disease progression during or after =< 1 prior systemic treatment Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan No tumor involving major vessels Zubrod performance status 0-1 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Creatinine =< 2 times upper limit of normal (ULN) Bilirubin =< 2 times ULN SGOT or SGPT =< 2 times ULN (5 times ULN if hepatic metastasis present) INR in range (usually between 2 and 3) No active bleeding No bleeding diathesis, active coagulopathy, or pathological condition that carries a high risk of bleeding No condition (e.g., gastrointestinal tract disease) affecting ability to take oral medication or requiring IV alimentation Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years At least 28 days since prior systemic treatment for this disease comprising 1 of the following: single chemotherapy agent/regimen; single immunotherapy agent/regimen; single investigational treatment agent/regimen At least 21 days since prior major surgery No prior sorafenib or any other agents targeting raf kinase or vascular endothelial growth factor (VEGF) or VEGF receptor No prior surgical procedures affecting absorption No concurrent systemic corticosteroid therapy Topical and/or inhaled steroids are allowed No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, and phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) No prophylactic granulocyte/platelet colony-stimulating factors during the first course of treatment Concurrent full-dose oral anticoagulants (e.g., warfarin) are allowed provided all of the following criteria are met: in-range INR ; stable dose of oral anticoagulant; no active bleeding or high risk of bleeding Stage IV disease No known varices No uncontrolled hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg No significant traumatic injury within the past 21 days No active, uncontrolled peptic ulcer disease
Sites / Locations
- Southwest Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (carboplatin, paclitaxel, sorafenib)
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. ]