Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026156
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2001-11-09
Brief Title:
S0027 Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older or With Performance Status 2
Status:
COMPLETED
Status Verified Date:
2013-02
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 followed by docetaxel in treating patients who have advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2 when treated with sequential vinorelbine and docetaxel Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
Determine the objective tumor response rates including confirmed and unconfirmed and complete and partial in patients treated with this regimen
Assess the dose delivered and the reported functional symptom status of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients
OUTLINE This is a multicenter study Patients are stratified according to age and performance status age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2 Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Beginning 2 weeks after the last dose of vinorelbine patients receive docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity
Quality of life is assessed at baseline at the beginning of courses 2-6 and at week 22
Patients are followed at week 22 every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A minimum of 95 patients 55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2 will be accrued for this study within 12-18 months Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2 when treated with sequential vinorelbine and docetaxel Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
Determine the objective tumor response rates including confirmed and unconfirmed and complete and partial in patients treated with this regimen
Assess the dose delivered and the reported functional symptom status of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients
OUTLINE This is a multicenter study Patients are stratified according to age and performance status age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2 Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Beginning 2 weeks after the last dose of vinorelbine patients receive docetaxel IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity
Quality of life is assessed at baseline at the beginning of courses 2-6 and at week 22
Patients are followed at week 22 every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A minimum of 95 patients 55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2 will be accrued for this study within 12-18 months Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2152003
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 |
|---|---|---|---|
| S0027 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |