Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00489944
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date May 2007

See also
  Status Clinical Trial Phase
Recruiting NCT01217398 - Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye Phase 2
Completed NCT00471471 - Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery Phase 1
Completed NCT00398073 - Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma N/A
Completed NCT00334776 - Vaccine Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00025181 - Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery Phase 1
Terminated NCT00002947 - Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer Phase 1
Completed NCT00897624 - Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma N/A
Completed NCT00003339 - Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma Phase 2
Completed NCT00084656 - Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma Phase 2
Completed NCT00705640 - Vaccine Therapy in Treating Patients With Advanced Melanoma Phase 1
Completed NCT00027742 - Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma Phase 2
Completed NCT00952939 - Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye N/A
Terminated NCT00005841 - Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma Phase 1
Completed NCT00072345 - Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma Phase 2
Completed NCT00089219 - Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma Phase 1/Phase 2
Completed NCT00243061 - AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma Phase 2
Completed NCT00445965 - Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer Phase 2
Terminated NCT00110123 - Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma Phase 3
Completed NCT00032045 - Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma Phase 2
Completed NCT00238329 - PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma Phase 2