Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: carboplatin; paclitaxel albumin-stabilized nanoparticle formulation
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin
      together with ABI-007 works in treating patients with stage IV melanoma that cannot be
      removed by surgery.
    

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