Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: carboplatin; paclitaxel; temozolomide
Intervention description: AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal; 100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal; 150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks
Intervention MeSH terms: Paclitaxel; Carboplatin; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. It is not yet known
      whether giving paclitaxel together with carboplatin is more effective than giving
      temozolomide alone in treating patients with melanoma.

      PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel
      together with carboplatin or giving temozolomide alone works in treating patients with stage
      IV melanoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed metastatic melanoma

               -  Stage IV disease

               -  Progressive disease

               -  No known standard therapy that is potentially curative or proven capable of
                  extending life expectancy exists

          -  Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone
             for progressive disease

          -  Measurable disease as defined by RECIST criteria

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 3 months

          -  ANC ≥ 1,500/mL

          -  Platelet count ≥ 100,000/mL

          -  Hemoglobin ≥ 9 g/dL

          -  Creatinine ≤ 2.5 x upper limit of normal (ULN)

          -  AST ≤ 3 x ULN

          -  Alkaline phosphatase ≤ 3.0 x 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, any of the
             following:

               -  Active infection

               -  NYHA class III or IV congestive heart failure

          -  No history of other malignancy within the past 5 years except for basal cell or
             squamous cell carcinoma of the skin treated with local resection only or carcinoma in
             situ of the cervix

          -  Willing to provide research blood samples

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  At least 4 weeks since prior radiotherapy

          -  At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the
             metastatic setting)

               -  No prior chemotherapy treatment with agents similar to study drugs

          -  No prior chemotherapy in the metastatic setting (for chemo-naive patients)

          -  No concurrent enrollment in a different clinical study in which investigational
             procedures or agents are being used

          -  No other concurrent investigational agents

          -  No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy