Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006484
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2002-01
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 It is not yet known which combination chemotherapy regimen is more effective for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer
Compare response rates in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to weight loss less than 5 vs 5 or more stage of disease IIIB vs IV and lactate dehydrogenase level normal vs abnormal Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1
Arm II Patients receive paclitaxel and carboplatin as in arm I Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for one year and then every 6 months for 2 years or until death
PROJECTED ACCRUAL Approximately 500 patients 250 per arm will be accrued for this study within 20 months
Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer
Compare response rates in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to weight loss less than 5 vs 5 or more stage of disease IIIB vs IV and lactate dehydrogenase level normal vs abnormal Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1
Arm II Patients receive paclitaxel and carboplatin as in arm I Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for one year and then every 6 months for 2 years or until death
PROJECTED ACCRUAL Approximately 500 patients 250 per arm will be accrued for this study within 20 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 |
|---|---|---|---|
| SWOG-S0003 | None | None | None |