Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068289
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2003-09-10
Brief Title:
Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of PS-341 NSC-681239 in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2004-08
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 Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have recurrent or refractory extensive-stage small cell lung cancer that was previously treated with platinum-based chemotherapy such as cisplatin carboplatin or oxaliplatin
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have recurrent or refractory extensive-stage small cell lung cancer that was previously treated with platinum-based chemotherapy such as cisplatin carboplatin or oxaliplatin
Detailed Description:
OBJECTIVES
Determine the efficacy of bortezomib in terms of response rate confirmed and unconfirmed complete and partial in patients with recurrent or refractory extensive stage small cell lung cancer previously treated with platinum-based therapy
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the overall survival of patients treated with this drug
Correlate selected molecular markers with outcomes in patients treated with this drug
OUTLINE Patients are stratified according to platinum-sensitivity status platinum sensitive temporarily closed to accrual as of 8104 vs platinum refractory temporarily closed to accrual as of 6104
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per stratum will be accrued for this study within 05-1 year
Determine the efficacy of bortezomib in terms of response rate confirmed and unconfirmed complete and partial in patients with recurrent or refractory extensive stage small cell lung cancer previously treated with platinum-based therapy
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the overall survival of patients treated with this drug
Correlate selected molecular markers with outcomes in patients treated with this drug
OUTLINE Patients are stratified according to platinum-sensitivity status platinum sensitive temporarily closed to accrual as of 8104 vs platinum refractory temporarily closed to accrual as of 6104
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per stratum will be accrued for this study within 05-1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0327 | None | None | None |