Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003281
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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
PURPOSE Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer
Determine the response rate and survival in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to length of time since prior treatment less than 3 months stratum A vs 3 months or more stratum B Stratum A closed to accrual effective 06202000
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3 Courses repeat every 4 weeks
Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment Patients who achieve complete remission receive a maximum of 6 courses of treatment Patients may then undergo prophylactic cranial irradiation andor thoracic radiotherapy at the discretion at the attending physician
Patients are followed every 3 months for 2 years and then at 3 years after study
Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer
Determine the response rate and survival in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to length of time since prior treatment less than 3 months stratum A vs 3 months or more stratum B Stratum A closed to accrual effective 06202000
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3 Courses repeat every 4 weeks
Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment Patients who achieve complete remission receive a maximum of 6 courses of treatment Patients may then undergo prophylactic cranial irradiation andor thoracic radiotherapy at the discretion at the attending physician
Patients are followed every 3 months for 2 years and then at 3 years after 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 |
|---|---|---|---|
| CDR0000066190 | REGISTRY | PDQ Physician Data Query | None |