Clinical trial NCT00434252 (phase 2, status: completed)
Conditions: melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: bevacizumab, carboplatin, paclitaxel, placebo
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form

          -  Age ≥ 18 years

          -  Metastatic melanoma (Stage IV)

          -  Histologically confirmed malignant melanoma with measurable or non-measurable disease

          -  Ability and willingness to comply with study and follow-up procedures

        Exclusion Criteria:

          -  Prior treatment for Stage IV disease with chemotherapy or biologic therapy such as
             interferon and interleukin-2

          -  Complete surgical resection or irradiation of all identifiable sites of disease at
             randomization

          -  Radiation therapy within 14 days prior to Day 1

          -  Prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelial
             growth factor (VEGF) pathway-targeted therapy

          -  Melanoma of ocular origin

          -  Known central nervous system (CNS) disease/brain metastases (history of brain disease
             or active disease)

          -  Life expectancy of < 12 weeks

          -  Current, recent, or planned participation in an experimental drug study other than a
             Genentech-sponsored bevacizumab cancer study

          -  Inadequate organ function

          -  History of other malignancies within 5 years of Day 1, except for tumors with a
             negligible risk for metastasis or death, such as adequately controlled basal cell
             carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix

          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or renders the patient at high risk from treatment
             complications

          -  Inadequately controlled hypertension

          -  History of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association (NYHA) Class II or greater CHF

          -  History of myocardial infarction or unstable angina within 6 months prior to Day 1

          -  History of stroke or transient ischemic attack within 6 months prior to Day 1

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
             peripheral arterial thrombosis within 6 months prior to Day 1

          -  History of hemoptysis within 1 month prior to Day 1

          -  Evidence of bleeding diathesis or significant coagulopathy (in the absence of
             therapeutic anticoagulation)

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1 or anticipation of need for major surgical procedure during the course
             of the study

          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular
             access device, within 7 days prior to Day 1

          -  History of abdominal fistula or gastrointestinal perforation within 6 months prior to
             Day 1

          -  Serious, non-healing wound, active ulcer, or untreated bone fracture

          -  Known hypersensitivity to any component of bevacizumab

          -  Pregnancy (positive pregnancy test) or lactation

          -  Current, ongoing treatment with full-dose warfarin