Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010218
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2001-02-02
Brief Title:
Karenitecin in Treating Patients With Relapsed or Refractory Non-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 Karenitecin IND 57250 In Patients With Relapsed or Refractory Non-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
PURPOSE Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy
Determine the effect of prior response to chemotherapy on response to this drug in these patients
Determine survival and failure-free survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE Patients are stratified according to response to prior chemotherapy relapsed vs refractory
Patients receive karenitecin IV over 60 minutes on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease after 6 courses may receive 2 additional courses beyond best response
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A minimum of 45 patients 25 for stratum I and 20 for stratum II will be accrued for this study within 12 months
Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy
Determine the effect of prior response to chemotherapy on response to this drug in these patients
Determine survival and failure-free survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE Patients are stratified according to response to prior chemotherapy relapsed vs refractory
Patients receive karenitecin IV over 60 minutes on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with responding disease after 6 courses may receive 2 additional courses beyond best response
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A minimum of 45 patients 25 for stratum I and 20 for stratum II 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 |
|---|---|---|---|
| CDR0000068456 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-30004 | None | None | None |