Inclusion Criteria:

- Histologically confirmed melanoma of the skin, mucosa, or unknown primary, diagnosed
with surgically unresectable distant metastases (stage IV according to AJCC).

- At least one measurable target lesion according to RECIST, assessed by CT or MRI
(tumor assessment by X-ray or ultrasonography only is not allowed).

- Access to a biopsy of ~1 cm3 from at least one metastatic lesion for in vitro
chemosensitivity testing. Cell suspensions from malignant effusions are also
eligible.

- No prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one
prior regimen of immunotherapy or targeted therapy in stage IV allowed).

- No evidence of brain/CNS metastases. Former history of brain/CNS metastases, which
have been treated successfully, and are no longer visible in CT/MRI is allowed.

- Last complete tumor assessment (CT or MRI of thorax, abdomen and brain) not older
than 14 days prior to registration, and not older than 5 weeks prior to onset of
study treatment.

- ECOG/WHO performance index of 0 or 1.

- Patients must have stopped any kind of previous antineoplastic therapy for at least 2
weeks prior to registration, and at least 4 weeks prior to treatment onset.

- Patients must not have concurrent or recent malignancies except for surgically cured
carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
Patients with previous malignancies, which have been treated with a subsequent
disease-free interval of at least 5 years, are eligible.

- Patient age ≥ 18 years.

- Adequate hematological, renal and liver function as defined by the following
laboratory values performed within 14 days prior to randomisation:

- absolute neutrophil count (ANC) ≥ 1.5 x 109/l

- platelet count ≥ 100 x 109/l

- hemoglobin ≥ 9 g/dl

- urea and serum creatinine ≤ 2 times upper normal limit (UNL)

- total and direct serum bilirubin ≤ 2 times UNL

- GOT or GPT ≤ 2.5 times UNL; ≤ 5 times UNL is allowed in case of liver metastasis

- alkaline phosphatase < 2.5 times UNL

- Female patients should not be pregnant or nursing. Women of childbearing potential
should be using a highly effective method of birth control (e.g. implants,
injectables, combined oral contraceptives, some IUDs, sexual abstinence or
vasectomised partner). For subjects using a hormonal contraceptive method,
information regarding the product under evaluation and its potential effect on the
contraceptive should be addressed.

- Male patients should use an effective method of contraception.

- Before registration, written informed consent must be given according to GCP
guidelines and national/local regulations. Patients must be willing and giving
informed consent to participation in the trial.

Exclusion Criteria:

- All metastatic lesions are surgically resectable.

- Prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one prior
regimen of immunotherapy or targeted therapy in stage IV allowed).

- Primary melanoma of the uvea / choroidea.

- Evidence of brain/CNS metastases. Former history of brain/CNS metastases, which have
been treated successfully, and are no longer visible in CT/MRI is allowed.

- ECOG/WHO performance index of 2 or higher

- Concurrent or recent malignancies except for surgically cured carcinoma in-situ of
the cervix and basal or squamous cell carcinoma of the skin. Patients with previous
malignancies, which have been treated with a subsequent disease-free interval of at
least 5 years, are eligible.

- Any severe or uncontrolled hematological, renal or liver dysfunction as defined by
the laboratory values given in Inclusion Criteria.

- Any clinically uncontrolled infectious disease including HIV positivity or
AIDS-related illness.

- Any female patients who are pregnant or nursing.

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be discussed with the patient before registration for the trial.