Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087048
Status:
TERMINATED
Last Update Posted:
2016-03-22
First Post:
2004-07-08
Brief Title:
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 such as topotecan work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer
PURPOSE This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride
Secondary
Determine the safety and toxic effects of this drug in these patients
Determine the recurrence-free survival of patients treated with this drug
Determine time to response and tumor response in patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE This is a non-randomized multicenter study
Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline day 1 of each course except course 1 at the end of study treatment and then every 3 months thereafter
Patients are followed at 7-14 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study
Primary
Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride
Secondary
Determine the safety and toxic effects of this drug in these patients
Determine the recurrence-free survival of patients treated with this drug
Determine time to response and tumor response in patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE This is a non-randomized multicenter study
Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline day 1 of each course except course 1 at the end of study treatment and then every 3 months thereafter
Patients are followed at 7-14 days and then every 3 months thereafter
PROJECTED ACCRUAL A total of 65 patients 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 |
|---|---|---|---|
| CWRU-050308 | None | None | None |
| CASE-HFHS-1503 | None | None | None |
| HFH-HFHS-1503 | None | None | None |
| HFH-HFHS-0205 | None | None | None |