Clinical trial NCT00626405 (phase 2, status: completed)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, temozolomide
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        -  Histologic confirmed diagnosis of malignant melanoma

               -  Stage IV disease

               -  Not amenable tosurgery

          -  Measurable disease with at least one lesion whose longest diameter canbe measured as ≥
             20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT

               -  No disease that is measurable by physical examination only

          -  No brain metastases per MRI or CT

          -  No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or
             tumor invading major blood vessels

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 4 months

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL (transfusion allowed)

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)

          -  AST ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Urine protein:creatinine ratio < 1.0 at screening ORproteinuria < 2+ by urine dipstick
             or protein ≤ 1 g by 24-hour urine collection

          -  Negative serum pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Active infection requiring parenteral antibiotics

          -  Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic)
             despite treatment

          -  NYHA class II-IV congestive heart failure

          -  Serious cardiac arrhythmia requiring medication

          -  Myocardial infarction or unstable angina within the past 6 months

          -  Clinically significant peripheral vascular disease

          -  Deep venous thrombosis or pulmonary embolus within the past year

          -  Active bleeding or pathological conditions that carry high risk of bleeding (e.g.,
             known esophageal varices)

          -  Serious, non-healing wound (including wounds healing by secondary intention), ulcer or
             bone fracture

          -  Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the
             past 6 months

          -  History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)

          -  Clinically significant stroke or TIA within the past 6 months

          -  Seizures not controlled with standardmedical therapy

          -  Peripheral neuropathy ≥ grade 2

          -  History of other malignancy within the past 5 years except basal cell or squamous cell
             carcinoma of the skin treatable with local resection only or carcinoma in situ of the
             cervix

          -  Significant traumatic injury within the past 4 weeks

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood
             per episode)

          -  Known hypersensitivity to any of the components of bevacizumab

          -  Known to be HIV positive

          -  Current or known history of hepatitis

          -  Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed

          -  No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap,
             anti-VEGFR Mab)

          -  No ongoing need for full-dose oral or parenteral anticoagulation

          -  No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg
             daily)

          -  No other investigational agents within the past 4 weeks

          -  No major surgical procedure or open biopsy within the past 4 weeks

          -  No fine needle aspirations or core biopsies within the past 7 days

          -  No prior chemotherapy in the metastatic setting

          -  No prior treatment with sunitinib malate or sorafenib

          -  No prior treatment with any taxane-based chemotherapy

          -  Patients who have had > 25% of their functional bone marrow irradiated are not
             eligible for this trial

          -  No adjuvant radiation therapy within the past 4 weeks

          -  More than 2 weeks since prior and no concurrent palliative radiation therapy

          -  No concurrent major surgical procedure

          -  No concurrent participation in another clinical study for procedures or agents that
             treat the same primary study malignancy