Clinical trial NCT00288041 (phase 2, status: completed)
Conditions: ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma, recurrent melanoma, stage iv 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, 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, bortezomib
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, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Criteria:

          -  No uncontrolled intercurrent illness including any of the following: ongoing or active
             infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac
             arrhythmia

          -  No psychiatric illness that would limit compliance with study requirements

          -  No other uncontrolled serious medical conditions (e.g., diabetes)

          -  No more than 1 prior cytotoxic chemotherapy regimen

          -  No more than 2 prior immunotherapy regimens either in adjuvant or metastatic setting

          -  At least 4 weeks since prior major radiotherapy or chemotherapy

          -  At least 8 weeks since prior monoclonal antibody therapy

          -  At least 4 weeks since prior immunotherapy or biologic therapy

          -  At least 3 weeks since prior surgery

          -  Recovered from prior therapies

          -  No prior therapy with bortezomib, paclitaxel, or carboplatin

          -  No other prior or concurrent chemotherapy, immunotherapy, radiotherapy, or any other
             therapy or supportive care considered investigational

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent prophylactic colony-stimulating factors

          -  Histologically confirmed malignant melanoma

          -  Patients with significant fluid retention, including ascites or pleural effusion, may
             be allowed at the discretion of the principal investigator

          -  No known brain metastases by brain imaging with contrast

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Routine urine analysis with predicted 24-hour urine protein < 500 mg OR 1+ proteinuria
             by urine dipstick with 24-hour urine protein < 500 mg

          -  Total bilirubin < 1.5 mg/dL

          -  AST =< 3 times ULN

          -  Creatinine =< 1.5 times ULN

          -  ECOG performance status (PS) 0, 1, or 2 (Karnofsky PS >= 60%)

          -  Life expectancy by physician estimate > 12 weeks

          -  Not pregnant or nursing

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

          -  Negative pregnancy test

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to bortezomib

          -  No peripheral neuropathy >= grade 2

          -  Manifestations of stage IV disease (e.g., cutaneous, uveal)

          -  All melanomas, regardless of origin, allowed

          -  Measurable disease, defined as at least one lesion whose longest diameter can be
             accurately measured as >= 2.0 cm with conventional techniques or as >= 1.0 cm with
             spiral CT scan

          -  No nonmeasurable disease only, including any of the following: bone lesions,
             leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast
             disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and
             followed by imaging techniques, cystic lesions

          -  Hemoglobin >= 9.0 g/dL