Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006017
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2000-07-05
Brief Title:
Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-06
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 It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the efficacy in terms of response rate in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks
Compare the response duration in patients treated with these regimens
Compare the toxicity profiles of these two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 or 1 vs 2 and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive rebeccamycin analogue IV over 1 hour on day 1
Arm II Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36-64 patients 18-32 per arm will be accrued for this study at a rate of 3-4 patients per month
Compare the efficacy in terms of response rate in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks
Compare the response duration in patients treated with these regimens
Compare the toxicity profiles of these two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 or 1 vs 2 and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive rebeccamycin analogue IV over 1 hour on day 1
Arm II Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36-64 patients 18-32 per arm will be accrued for this study at a rate of 3-4 patients per month
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-91 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| U01CA063200 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-1599 | None | None | None |