Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma

Conditions
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Intraocular Melanoma

Intervention / Treatment
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* Drug: cisplatin
* Drug: sunitinib malate
* Drug: tamoxifen citrate
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of ocular melanoma High-risk disease, defined by any of the following: Large choroidal tumors with a basal diameter ≥ 16 mm and/or tumor thickness ≥ 10 mm (T3) Extrascleral extension (T4) Ciliary body involvement Epithelioid cell type only Have undergone appropriate primary treatment for ocular melanoma No measurable metastatic disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 1,200/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9.0 g/dL Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min AST and ALT ≤ 3 times upper limit of normal Pancreatic enzymes normal Thyroid function normal or stable on replacement therapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Cardiac ejection fraction ≥ 50% by MUGA or ECHO No myocardial infarction within the past 6 months No congestive heart failure requiring medication No history of pulmonary disease requiring supplemental oxygen No dyspnea at rest No active infection No chronic underlying immunodeficiency disease No other serious illness that would preclude patient safety, in the opinion of the investigator No other cancer within the past 5 years except nonmelanoma skin cancer or cervical cancer No thromboembolic disease within the past 6 months PRIOR CONCURRENT THERAPY: No prior sunitinib malate, tamoxifen citrate, or cisplatin No other concurrent chemotherapy, radiotherapy, or surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: sunitinib malate|nan|
|Drug: tamoxifen citrate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 
| Overall survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, epithelioid cell intraocular melanoma, stage IIB intraocular melanoma, stage IIIA intraocular melanoma, stage IIIB intraocular melanoma, stage IIIC intraocular melanoma, stage IV intraocular melanoma