Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489944
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2007-06-20
Brief Title:
Sunitinib Tamoxifen and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
Sponsor:
San Diego Pacific Oncology Hematology Associates
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Pilot Trial of Sutent Tamoxifen and Cisplatin in Patients With High-Risk Ocular Melanoma
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| POHA-0604 | None | None | None |