Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021008
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-07-11
Brief Title:
ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients With Non-Small Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen
Status:
UNKNOWN
Status Verified Date:
2001-09
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 ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy II Assess the safety and tolerability of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine the efficacy of this drug in terms of time to death time to disease progression disease control and duration of response in these patients V Assess the therapy outcome index in terms of disease-related symptom relief of these patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy 12 weeks or less vs more than 12 weeks Patients receive ZD0473 IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the beginning of each course and then every 6 weeks for 1 year after completion of study Patients are followed at 30 days after study completion and every 6 weeks for 1 year
PROJECTED ACCRUAL A total of 32-73 patients 23-56 per stratum 1 and 9-17 per stratum 2 will be accrued for this study within approximately 9 months
OUTLINE This is a multicenter study Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy 12 weeks or less vs more than 12 weeks Patients receive ZD0473 IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the beginning of each course and then every 6 weeks for 1 year after completion of study Patients are followed at 30 days after study completion and every 6 weeks for 1 year
PROJECTED ACCRUAL A total of 32-73 patients 23-56 per stratum 1 and 9-17 per stratum 2 will be accrued for this study within approximately 9 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 |
|---|---|---|---|
| UCLA-000307201A | None | None | None |
| ZENECA-0473IL0003 | None | None | None |
| NCI-G01-1974 | None | None | None |