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

Conditions:Skin Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:May 2007

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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


- 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.


- 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


- 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

- No other cancer within the past 5 years except nonmelanoma skin cancer or cervical

- No thromboembolic disease within the past 6 months


- No prior sunitinib malate, tamoxifen citrate, or cisplatin

- No other concurrent chemotherapy, radiotherapy, or surgery
We found this trial at
Encinitas, CA
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