Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008333
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2001-01-06
Brief Title:
Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age A Phase II Trial of Efficacy 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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate in elderly patients with stage IIIB or IV non-small cell lung cancer treated with oral vinorelbine II Determine the time to progression in patients treated with this drug III Determine the toxicity of this drug in these patients IV Determine whether there is a perceived preference for this oral administration in these patients V Determine the quality of life of these patients when treated with this drug VI Assess individual variation in responses pharmacokinetic parameters andor biological correlates in patients treated with this drug
OUTLINE Patients receive oral vinorelbine on days 1 8 15 and 22 Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and after 8 weeks of therapy Patients are followed every 3 months for 5 years
OUTLINE Patients receive oral vinorelbine on days 1 8 15 and 22 Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and after 8 weeks of therapy 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 |
|---|---|---|---|
| CDR0000068398 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02369 | REGISTRY | None | None |