Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110019
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2005-05-03
Brief Title:
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Phase III Trial of Carboplatin Paclitaxel and Sorafenib Versus Carboplatin Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-07
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 randomized phase III trial studies carboplatin paclitaxel and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery 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 tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma
Detailed Description:
PRIMARY OBJECTIVES
I To compare the overall survival of patients with unresectable stage III or stage IV melanoma treated with carboplatin paclitaxel and placebo versus carboplatin paclitaxel and sorafenib sorafenib tosylate
II To compare progression-free survival response rate and safety of patients with unresectable stage III or stage IV melanoma treated with carboplatin paclitaxel and placebo versus carboplatin paclitaxel and sorafenib
III To analyze the pharmacokinetic and pharmacogenetic properties of sorafenib including angiogenesis monooxygenases polymorphisms and multidrug resistance MDR
IV To assess the association of expression markers in the patient tumor with clinical outcome
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Patients also receive sorafenib tosylate orally PO twice daily BID approximately every 12 hours on days 2-19
Arm II Patients receive paclitaxel and carboplatin as in Arm I Patients also receive placebo PO BID approximately every 12 hours on days 2-19
In both arms treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or who achieve a partial response or complete response may continue to receive sorafenib tosylate or placebo alone BID approximately every 12 hours on days 1-21 Courses with sorafenib tosylate or placebo repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
I To compare the overall survival of patients with unresectable stage III or stage IV melanoma treated with carboplatin paclitaxel and placebo versus carboplatin paclitaxel and sorafenib sorafenib tosylate
II To compare progression-free survival response rate and safety of patients with unresectable stage III or stage IV melanoma treated with carboplatin paclitaxel and placebo versus carboplatin paclitaxel and sorafenib
III To analyze the pharmacokinetic and pharmacogenetic properties of sorafenib including angiogenesis monooxygenases polymorphisms and multidrug resistance MDR
IV To assess the association of expression markers in the patient tumor with clinical outcome
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Patients also receive sorafenib tosylate orally PO twice daily BID approximately every 12 hours on days 2-19
Arm II Patients receive paclitaxel and carboplatin as in Arm I Patients also receive placebo PO BID approximately every 12 hours on days 2-19
In both arms treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or who achieve a partial response or complete response may continue to receive sorafenib tosylate or placebo alone BID approximately every 12 hours on days 1-21 Courses with sorafenib tosylate or placebo repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-02978 | REGISTRY | None | None |
| E2603 | OTHER | None | None |
| E2603 | OTHER | None | None |
| U10CA180820 | NIH | None | None |