Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030433
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2002-02-14
Brief Title:
S0119 Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial Of Gemcitabine NSC-613327 And Irinotecan NSC-616348 In Patients With Untreated Extensive Stage Small Cell Lung Cancer SCLC
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan
Determine the response rates confirmed and unconfirmed complete and partial of patients treated with this regimen
Determine the overall toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 12 months
Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan
Determine the response rates confirmed and unconfirmed complete and partial of patients treated with this regimen
Determine the overall toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 12 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 |
|---|---|---|---|
| S0119 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |