Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
- Conditions
- Intraocular Melanoma
- Registration Number
- NCT00489944
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival Overall survival Toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
🇺🇸Encinitas, California, United States