Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084487
Status:
TERMINATED
Last Update Posted:
2014-05-23
First Post:
2004-06-10
Brief Title:
Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of XL119 Rebeccamycin Analogue in Relapsed Sensitive Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy such as rebeccamycin analog work in different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy
Detailed Description:
OBJECTIVES
I Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy
II Determine the duration of remission and survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed annually
PROJECTED ACCRUAL A total of 20-39 patients will be accrued for this study within 15 months
I Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy
II Determine the duration of remission and survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed annually
PROJECTED ACCRUAL A total of 20-39 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| NCI-2012-02587 | REGISTRY | None | None |
| NCI-1990 | None | None | None |
| CASE-1503 | None | None | None |
| CDR0000365315 | None | None | None |
| CASE-CWRU-1503 | OTHER | None | None |
| 1990 | OTHER | None | None |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | CTEP | httpsreporternihgovquickSearchP30CA043703 |