Clinical trial NCT00602576 (phase 2, status: completed)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: sorafenib tosylate, temozolomide
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed melanoma

               -  Metastatic or unresectable disease

          -  Measurable disease by RECIST criteria

               -  Cutaneous lesions measuring at least 1 cm will be considered measurable disease

          -  Brain metastases allowed provided patient completed radiotherapy, if radiotherapy was
             clinically indicated at the time of diagnosis, AND discontinued steroids prior to
             study enrollment

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  WBC ≥ 3,000/mm³

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum creatinine ≤ 2.0 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN if Gilbert's disease is present)

          -  AST or ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)

          -  INR ≤ 1.5 (if on anticoagulation, baseline INR must be < 1.5 before starting
             anticoagulation)

          -  PTT normal

          -  No other concurrent malignancies, except basal cell or squamous cell skin cancer,
             carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast

          -  No concurrent serious illness including, but not limited to, any of the following:

               -  Ongoing or active infection requiring parenteral antibiotics

               -  Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
                  myocardial infarction, unstable angina)

               -  New York Heart Association class II-IV congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

               -  Peripheral vascular disease ≥ grade II within the past year

               -  Psychiatric illness/social situation that would limit compliance with study
                  requirements

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No HIV positivity

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  Prior radiotherapy allowed

               -  If radiotherapy has been administered to a lesion, there must be radiographic
                  evidence of progression of that lesion for that lesion to constitute measurable
                  disease or to be included in the measured target lesions

          -  Prior temozolomide or sorafenib tosylate allowed

          -  At least 4 weeks since prior chemotherapy

          -  At least 4 weeks since prior active immunotherapy (aldesleukin, interferon,
             sargramostim [GM-CSF], or CTLA-4)

          -  At least 4 weeks since prior and no other concurrent investigational anticancer
             therapy (except vaccines)

          -  No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
             carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)