Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329641
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2006-05-23
Brief Title:
Sorafenib Carboplatin and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of BAY 43-9006 Sorafenib NSC-724772 in Combination With Carboplatin and Paclitaxel in Patients With Metastatic Uveal Melanoma
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
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:
This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sorafenib may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate confirmed and unconfirmed complete and partial response of patients with stage IV uveal melanoma treated with sorafenib carboplatin and paclitaxel
SECONDARY OBJECTIVES
I Determine the overall and progression-free survival of patients treated with this regimen
II Determine the toxic effects of this regimen in these patients III Determine preliminarily the relationship between clinical outcomes and baseline microvessel density MVD in tumor specimens changes in vascular endothelial growth factor VEGF levels in plasma and urine changes in MVD changes in VEGF receptor-2 phosphorylation in tumor andor changes in ERK 12 phosphorylation in stimulated lymphocytes and tumor
OUTLINE This is a non-randomized open-label multicenter study
Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice daily on days 2-19 Treatment repeats every 21 days for up to 6 courses After 6 courses patients continue to receive oral sorafenib alone twice daily in the absence of disease progression or unacceptable toxicity
Note If sorafenib is discontinued prior to course 6 patients may continue to receive carboplatin and paclitaxel for up to 6 courses if carboplatin and paclitaxel are discontinued prior to course 6 patients may continue to receive sorafenib alone twice daily on days 1-21 of each course in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
I Determine the response rate confirmed and unconfirmed complete and partial response of patients with stage IV uveal melanoma treated with sorafenib carboplatin and paclitaxel
SECONDARY OBJECTIVES
I Determine the overall and progression-free survival of patients treated with this regimen
II Determine the toxic effects of this regimen in these patients III Determine preliminarily the relationship between clinical outcomes and baseline microvessel density MVD in tumor specimens changes in vascular endothelial growth factor VEGF levels in plasma and urine changes in MVD changes in VEGF receptor-2 phosphorylation in tumor andor changes in ERK 12 phosphorylation in stimulated lymphocytes and tumor
OUTLINE This is a non-randomized open-label multicenter study
Patients receive carboplatin IV and paclitaxel IV once on day 1 and oral sorafenib twice daily on days 2-19 Treatment repeats every 21 days for up to 6 courses After 6 courses patients continue to receive oral sorafenib alone twice daily in the absence of disease progression or unacceptable toxicity
Note If sorafenib is discontinued prior to course 6 patients may continue to receive carboplatin and paclitaxel for up to 6 courses if carboplatin and paclitaxel are discontinued prior to course 6 patients may continue to receive sorafenib alone twice daily on days 1-21 of each course in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| NCI-2009-00777 | REGISTRY | None | None |
| CDR0000467188 | None | None | None |
| S0512 | None | None | None |
| S0512 | OTHER | None | None |
| S0512 | OTHER | None | None |