Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003589
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
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 in treating advanced non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the overall survival between paclitaxelcisplatin arm I gemcitabinecisplatin arm II and paclitaxelgemcitabine arm III in patients with advanced non-small cell lung cancer II Determine the response rate duration of response progression-free survival toxicity and quality of life of these patients randomized in these three treatment arms
OUTLINE This is randomized multicenter study Patients are stratified according to performance status 0-1 vs 2 and stage of disease locally advanced vs metastatic Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks arm I gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks arm II or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks arm III Patients receive at least 2 courses of treatment In the absence of unacceptable toxicity and disease progression patients may receive up to 6 courses of treatment Quality of life is assessed before during and at the end of treatment then every 6 weeks until disease progression and then every 3 months until death Patients are followed every 6 weeks until disease progression then every 3 months until death
PROJECTED ACCRUAL A total of 450 patients 150 patients per arm will be accrued into this study over 36 months
OUTLINE This is randomized multicenter study Patients are stratified according to performance status 0-1 vs 2 and stage of disease locally advanced vs metastatic Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks arm I gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks arm II or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks arm III Patients receive at least 2 courses of treatment In the absence of unacceptable toxicity and disease progression patients may receive up to 6 courses of treatment Quality of life is assessed before during and at the end of treatment then every 6 weeks until disease progression and then every 3 months until death Patients are followed every 6 weeks until disease progression then every 3 months until death
PROJECTED ACCRUAL A total of 450 patients 150 patients per arm will be accrued into this study over 36 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 |
|---|---|---|---|
| EORTC-08975 | None | None | None |