Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045162
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2002-09-06
Brief Title:
S0124 Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Randomized Phase III Trial of Cisplatin and Irinotecan NSC-616348 Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer E-SCLC
Status:
COMPLETED
Status Verified Date:
2018-07
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 whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide
Compare the objective response rate and progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients
Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of metastatic sites single vs multiple lactic dehydrogenase no greater than upper limit of normal ULN vs greater than ULN and weight loss in the past 6 months 5 or less vs more than 5 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on days 1 8 and 15 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 4 weeks
Arm II Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 3 weeks
Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 620 patients 310 per treatment arm will be accrued for this study within 4 years
Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide
Compare the objective response rate and progression-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients
Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to number of metastatic sites single vs multiple lactic dehydrogenase no greater than upper limit of normal ULN vs greater than ULN and weight loss in the past 6 months 5 or less vs more than 5 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on days 1 8 and 15 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 4 weeks
Arm II Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 3 weeks
Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 620 patients 310 per treatment arm will be accrued for this study within 4 years
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 |
|---|---|---|---|
| S0124 | OTHER | None | None |
| S0124 | OTHER | None | None |
| S0124 | OTHER | None | None |
| U10CA032102 | NIH | CALGB | httpsreporternihgovquickSearchU10CA032102 |