Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132054
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-08-16
Brief Title:
Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer
Sponsor:
Japan Multinational Trial Organization
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
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 such as amrubicin and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer
Secondary
Determine the response rate in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the frequency and severity of adverse events in patients treated with this regimen
OUTLINE This is a dose-escalation study of amrubicin
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 13 or 33 of patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 6-30 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer
Secondary
Determine the response rate in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the frequency and severity of adverse events in patients treated with this regimen
OUTLINE This is a dose-escalation study of amrubicin
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 13 or 33 of patients experience dose-limiting toxicity An additional 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 6-30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000439464 | REGISTRY | PDQ Physician Data Query | None |