| Inclusion Criteria: | 1) 1. Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV).
2) No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) and/or vaccines is permitted. Prior treatments should be completed 4 weeks prior to enrollment in the study.
3) Male or non-pregnant and non-lactating female, and >/= 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta-Subunit of Human Chorionic Gonadotropin (ß-hCG) within 72 hours prior to first study drug administration.
4) (Continued #3) If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator during the period of administration of dacarbazine or ABI-007. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Summary of Product Characteristics or Prescribing Information provided in the study manual.
5) History of malignancy in the last 5 years; patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.
6) Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion.
7) Patient has the following blood counts at Baseline: 1) Absolute Neutrophil Count (ANC) >/= 1.5 x 10^9 cells/L; 2) platelets >/= 100 x 10^9 cells/L; 3) Hemoglobin (Hgb) >/= 9 g/dL.
8) Patient has the following blood chemistry levels at Baseline: 1) aspartate aminotransferase AST serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase ALT serum glutamic pyruvic transaminase (SGPT) </= 2.5x upper limit of normal range (ULN); </= 5.0 xULN if hepatic metastases present; 1) total bilirubin </= ULN; 2) creatinine </= 1.5 mg/dL, lactic dehydrogenase LDH </= 2.0 x ULN^a.
9) Expected survival of > 12 weeks.
10) Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
11) Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities. |