Clinical trial NCT00404235 (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
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed unresectable stage IV melanoma

          -  Measurable disease

          -  Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted
             protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic
             patients must be willing to submit a repeat biopsy at time of tumor progression)

          -  Brain metastases allowed provided they were previously treated with no progression for
             ≥ 3 months

               -  Patients with known brain metastases may receive concurrent steroid treatment

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 3 months

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (may be transfused to meet this requirement)

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

          -  Total bilirubin ≤ 1.5 times ULN (elevated bilirubin allowed in patients with
             documented Gilbert's syndrome)

          -  AST ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 1 month after
             completion of study therapy

          -  No uncontrolled intercurrent illness including, but not limited to, the following:

               -  Active infection

               -  Congestive heart failure (New York Heart Association class III-IV heart disease)

          -  No peripheral neuropathy ≥ grade 2

          -  No other malignancy within the past 5 years except basal cell or squamous cell
             carcinoma of the skin previously treated with local resection only or carcinoma in
             situ of the cervix

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  At least 4 weeks since prior radiotherapy

          -  At least 4 weeks since prior interferon or interleukin-2

          -  At least 4 weeks since prior chemotherapy (cohort 1 )

          -  No prior chemotherapy in the metastatic setting (cohort 2)

          -  No prior treatment for melanoma with any of the following agents:

               -  Platinum chemotherapy (e.g., carboplatin or cisplatin)

               -  Taxanes (e.g., paclitaxel or docetaxel)

               -  Paclitaxel albumin-stabilized nanoparticle formulation (ABI-007)

          -  No other concurrent chemotherapy

          -  No other concurrent investigational agents

          -  No concurrent radiotherapy, including palliative radiotherapy