Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003828
Status:
COMPLETED
Last Update Posted:
2012-08-22
First Post:
1999-11-01
Brief Title:
S9804 Vinorelbine in Treating Patients With Stage IV Melanoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of Vinorelbine Tartrate Navelbine in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated
Detailed Description:
OBJECTIVES I Evaluate the response rate complete or partial of patients with disseminated stage IV melanoma treated with vinorelbine II Assess the qualitative and quantitative toxic effects of vinorelbine in these patients
OUTLINE Patients receive vinorelbine by IV over 6 to 10 minutes weekly Treatment continues in the absence of disease progression unacceptable toxicity or complete response to therapy Patients are followed every 3 months for 2 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
OUTLINE Patients receive vinorelbine by IV over 6 to 10 minutes weekly Treatment continues in the absence of disease progression unacceptable toxicity or complete response to therapy Patients are followed every 3 months for 2 years and every 6 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
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 | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9804 | OTHER | None | None |