Clinical trial NCT00255762 (phase 2, status: completed)
Conditions: recurrent melanoma, stage iv melanoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: carboplatin, paclitaxel
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
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed melanoma

               -  Unresectable stage IV disease

               -  Evidence of metastatic disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

          -  No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)

          -  No tumor invasion of major blood vessels

          -  No history of primary brain tumor or other CNS disease

          -  No brain metastases by MRI or CT scan

          -  Performance status - ECOG 0-2

          -  More than 4 months

          -  Absolute granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (transfusion allowed)

          -  No active bleeding

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST ≤ 3 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN

          -  INR ≤ 1.5 times ULN

          -  PTT normal

          -  No known esophageal varices

          -  Creatinine ≤ 1.5 times ULN

          -  Urine protein creatinine ratio ≤ 0.5

          -  Urine protein < 1 g/24-hr urine collection

          -  No New York Heart Association class II-IV congestive heart failure

          -  No serious cardiac arrhythmia requiring medication

          -  No myocardial infarction within the past 6 months

          -  No unstable angina within the past 6 months

          -  No clinically significant peripheral vascular disease

          -  No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mmHg despite
             antihypertensive therapy)

          -  No clinically significant stroke within the past 6 months

          -  No deep vein thrombosis within the past year

          -  No other vascular abnormality

          -  No pulmonary embolus within the past year

          -  No history of abdominal fistula

          -  No gastrointestinal perforation

          -  No intra-abdominal abscess within the past 4 weeks

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study therapy

          -  No other pathological condition that would confer a high risk of bleeding

          -  No active infection requiring parenteral antibiotics

          -  No serious nonhealing wound (including wounds healing by secondary intention), ulcer,
             or bone fracture

          -  No peripheral neuropathy ≥ grade 2

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to the study drugs

          -  No uncontrolled seizures

          -  No other uncontrolled illness

          -  No significant traumatic injury within the past 4 weeks

          -  No prior antivascular endothelial growth factors (VEGF), including any of the
             following:

               -  Bevacizumab

               -  VEGF Trap

               -  Anti-VEGF receptor monoclonal antibody

               -  Small molecular tyrosine kinase inhibitors of VEGF receptors

          -  No more than 1 prior systemic chemotherapy regimen

          -  No prior carboplatin or paclitaxel

          -  No other concurrent chemotherapy

          -  More than 4 weeks since prior radiotherapy

          -  No prior radiotherapy to > 25% of bone marrow

          -  No concurrent radiotherapy

          -  At least 4 weeks since prior major surgical procedure or open biopsy

          -  At least 1 week since prior fine-needle aspiration or core biopsy

          -  No concurrent major surgery

          -  More than 4 weeks since prior systemic therapy

          -  No concurrent full-dose oral or parenteral anticoagulation

               -  No concurrent antiplatelet therapy except low-dose aspirin (i.e., 81 mg of oral
                  aspirin daily) allowed

          -  No other concurrent experimental drugs