Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004096
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining carboplatin and vinorelbine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of combining carboplatin and vinorelbine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of chemotherapy with carboplatin and vinorelbine in patients with stage IIIB or IV non-small cell lung cancer II Determine the maximum tolerated dose and dose limiting toxicities of this regimen in these patients III Determine the response rate and survival of these patients after this treatment
OUTLINE This is a dose escalation study of vinorelbine Patients receive carboplatin IV over 30 minutes followed by vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study over 6-12 months
OUTLINE This is a dose escalation study of vinorelbine Patients receive carboplatin IV over 30 minutes followed by vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study over 6-12 months
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 |
|---|---|---|---|
| NU-99L2 | None | None | None |
| NCI-G99-1589 | None | None | None |