Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
Condition: Ciliary Body and Choroid Melanoma, Medium/Large Size; Extraocular Extension Melanoma; Iris Melanoma; Metastatic Intraocular Melanoma; Recurrent Intraocular Melanoma
MeSH terms: Melanoma; Uveal Neoplasms
Intervention: carboplatin; paclitaxel; sorafenib tosylate
Intervention description: Given IV; Given IV; Given orally
Intervention MeSH terms: Paclitaxel; Carboplatin; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib works when given together with carboplatin
      and paclitaxel in treating patients with stage IV melanoma of the eye. 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 may
      help carboplatin and paclitaxel work better by making tumor cells more sensitive to the
      drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed
      for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with
      carboplatin and paclitaxel may kill more tumor cells.
    

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