Intraocular Melanoma Clinical Trial
Official title:
A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor
and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such
as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. Giving sunitinib together with
tamoxifen and cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib
together with tamoxifen and cisplatin works in treating patients with high-risk ocular
melanoma.
OBJECTIVES:
- Determine the effect of adjuvant sunitinib malate, tamoxifen citrate, and cisplatin on
disease-free survival and overall survival of patients with high-risk ocular melanoma
who have undergone primary therapy.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a pilot study.
Patients receive oral sunitinib malate once daily on days 1-21, oral tamoxifen citrate twice
daily on days 1-7, and cisplatin IV on days 2 and 3. Treatment repeats every 28 days for 4
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 2 years.
;
Primary Purpose: Treatment
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