Clinical trial NCT00329641 (phase 2, status: completed)
Conditions: ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, H05.823, H05.821, H05.822, H05.829, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, Z96.1, T85.22XS, T85.21XS, T85.22XA, T85.22XD, T85.21XA, T85.21XD, Z96.1, T85.22XS, T85.21XS, T85.22XA, T85.22XD, T85.21XA, T85.21XD
Drugs: carboplatin, paclitaxel, sorafenib tosylate
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
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