Melanoma (Skin) Clinical Trial
Official title:
A Phase II Trial of Carboplatin (CBDCA) and ABI-007(ABX) in Patients With Unresectable Stage IV Melanoma
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.
OBJECTIVES:
Primary
- Assess the safety and antitumor activity of carboplatin and paclitaxel
albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable
stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
(Cohort 1)
- Assess the safety and antitumor activity of this regimen in patients with unresectable
stage IV melanoma who have received prior chemotherapy for their metastatic disease.
(Cohort 2)
Secondary
- Describe the impact of this regimen on parameters of immune function and angiogenesis in
these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy
for metastatic disease (yes vs no).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30
minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats
every 28 days for at least 8 courses in the absence of disease progression or unacceptable
toxicity.
Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic
and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore
the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme
techniques for angiogenesis markers.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.
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