A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Toxicity
Disease-free survival
Overall survival
次要结局
未报告次要终点