Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003917
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
1999-11-01
Brief Title:
Topotecan in Treating Patients With Relapsed 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 Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy
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 It is not yet known if topotecan is more effective given by infusion or by mouth
PURPOSE Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy
PURPOSE Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy
Detailed Description:
OBJECTIVES I Compare the response rate response duration time to response time to progression and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan II Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population III Compare the quality of life in these patients
OUTLINE This is randomized multicenter study Patients are stratified according to gender liver metastases yes vs no and duration of response to prior chemotherapy 6 months or less vs greater than 6 months Patients are randomized to one of two treatment arms Arm I Patients receive topotecan IV over 30 minutes on days 1-5 Arm II Patients receive topotecan orally on days 1-5 Treatment repeats every 3 weeks in the absence of unacceptable toxicity Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response Patients with stable disease should receive at least 4 courses Quality of life is assessed Patients are followed every 3 months
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study
OUTLINE This is randomized multicenter study Patients are stratified according to gender liver metastases yes vs no and duration of response to prior chemotherapy 6 months or less vs greater than 6 months Patients are randomized to one of two treatment arms Arm I Patients receive topotecan IV over 30 minutes on days 1-5 Arm II Patients receive topotecan orally on days 1-5 Treatment repeats every 3 weeks in the absence of unacceptable toxicity Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response Patients with stable disease should receive at least 4 courses Quality of life is assessed Patients are followed every 3 months
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study
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-G99-1524 | None | None | None |
| CWRU-SKF-1598 | None | None | None |
| SB-104864-A396 | None | None | None |