Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194727
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2005-09-13
Brief Title:
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer A Phase II Trial With Molecular Correlates
Status:
COMPLETED
Status Verified Date:
2012-09
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:
The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects The study is designed to assess the safety and effectiveness of this combination therapy Safety will be assessed by analyzing the types of toxicity the severity of toxicity and the need for dose modification or delay due to toxicity Effectiveness will be assessed by analyzing response rates time to treatment failure time to progression and overall survival Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer
Detailed Description:
Single-agent chemotherapy is rarely curative in advanced breast cancer Combination regimens are the next logical step in the attempt to improve tumor response rates and prolong survival Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue In addition vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy and probably improved toxicity over its predecessors in the treatment of breast cancer We propose combining these two agents As these two drugs have non-overlapping toxicities and differing mechanisms of action we anticipate being able to deliver both drugs in near full dose
Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis
Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis
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 |
|---|---|---|---|
| 02-1544-A 06 | OTHER | UW Human Subjects Division | None |