Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022152
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-08-10
Brief Title:
Vinorelbine in Treating Older Women With Stage IV Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients 65 Years of Age A Trial of Efficacy Toxicity and Patients Perceived Preference for Oral Therapy
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating older women who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine
Determine the toxicity profile of this drug in these patients
Determine the time to progression in patients treated with this drug
Determine the quality of life of patients treated with this drug
Assess individual variation in responses toxicity andor activity pharmacokinetic parameters andor biologic correlates due to genetic differences in enzymes involved in the transport metabolism andor mechanism of action of this drug in these patients
OUTLINE Patients receive oral vinorelbine once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then after completion of the second course
Patients are followed every 3 months for 5 years
Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine
Determine the toxicity profile of this drug in these patients
Determine the time to progression in patients treated with this drug
Determine the quality of life of patients treated with this drug
Assess individual variation in responses toxicity andor activity pharmacokinetic parameters andor biologic correlates due to genetic differences in enzymes involved in the transport metabolism andor mechanism of action of this drug in these patients
OUTLINE Patients receive oral vinorelbine once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then after completion of the second course
Patients are followed every 3 months for 5 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 |
|---|---|---|---|
| NCI-2012-02395 | REGISTRY | None | None |
| CDR0000068790 | REGISTRY | PDQ Physician Data Query | None |