Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041015
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
An Open-Label Multicenter Randomized Phase III Study Comparing Oral TopotecanCisplatin Versus EtoposideCisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
Status:
COMPLETED
Status Verified Date:
2014-01
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 in treating extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide
Compare the response rates response duration and time to progression in patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the patient-perceived disease status and well being in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to gender ECOG performance status 0 vs 1 vs 2 lactate dehydrogenase less than 15 times upper limit of normal ULN vs 15 times ULN or greater and country Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5
Arm II Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline prior to each course at 4 weeks after study and then every 4 weeks for 16 weeks
Patients are followed at 4 weeks every 4 weeks for 16 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 760 patients 380 per treatment arm will be accrued for this study within 18 months
Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide
Compare the response rates response duration and time to progression in patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the patient-perceived disease status and well being in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to gender ECOG performance status 0 vs 1 vs 2 lactate dehydrogenase less than 15 times upper limit of normal ULN vs 15 times ULN or greater and country Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5
Arm II Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline prior to each course at 4 weeks after study and then every 4 weeks for 16 weeks
Patients are followed at 4 weeks every 4 weeks for 16 weeks and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 760 patients 380 per treatment arm will be accrued for this study within 18 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 |
|---|---|---|---|
| NCI-G02-2092 | None | None | None |
| CWRU-070144 | None | None | None |
| SB-389 | None | None | None |
| SB-SKF-104864A | None | None | None |
| SB-SKF-1501 | None | None | None |