Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014547
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-04-10
Brief Title:
BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen
Status:
UNKNOWN
Status Verified Date:
2002-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 BBR 3464 in treating patients who have metastatic small cell lung cancer that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of BBR 3464 in treating patients who have metastatic small cell lung cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the efficacy of BBR 3464 in terms of response rate in patients with sensitive or refractory metastatic small cell lung cancer II Determine the duration of response and time to progression in patients treated with this drug III Determine the overall survival of patients treated with this drug IV Determine the incidence and severity of toxic effects of this drug in this patient population V Determine the pharmacokinetics of this drug in this patient population
OUTLINE This is a multicenter study Patients are stratified according to disease refractory vs sensitive Patients receive BBR 3464 IV over 1 hour on day 1 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease may receive up to 6 courses of therapy Patients without progressive disease after 6 courses may continue treatment at the investigators discretion Patients are followed every 9 weeks for 3 years
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to disease refractory vs sensitive Patients receive BBR 3464 IV over 1 hour on day 1 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease may receive up to 6 courses of therapy Patients without progressive disease after 6 courses may continue treatment at the investigators discretion Patients are followed every 9 weeks for 3 years
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum 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-V01-1653 | None | None | None |
| THERADEX-TPT-II-04 | None | None | None |
| NOVUSPHARMA-TPT-II-04 | None | None | None |