Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
Recruitment status was: Recruiting
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.
Drug: sunitinib malate
Drug: tamoxifen citrate
Procedure: adjuvant therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma|
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489944
|United States, California|
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas|
|Encinitas, California, United States, 92024|
|Principal Investigator:||Edward F. McClay, MD||San Diego Pacific Oncology & Hematology Associates|