Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098462
Status:
WITHDRAWN
Last Update Posted:
2012-10-04
First Post:
2004-12-07
Brief Title:
Gefitinib and Sirolimus in Treating Patients With Recurrent or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Trial of ZD1839 Iressa and Rapamycin Rapamune in Patients With Advanced Non Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn as study never opened
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as sirolimus work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sometimes when chemotherapy is given it does not stop the growth of tumor cells The tumor is said to be resistant to chemotherapy Giving gefitinib together with sirolimus may reduce drug resistance and allow the tumor cells to be killed
PURPOSE This phase III trial is studying the side effects and best dose of sirolimus when given with gefitinib and to see how well they work in treating patients with recurrent or refractory stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of sirolimus when given with gefitinib and to see how well they work in treating patients with recurrent or refractory stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer
Secondary
Determine the overall response rate complete response CR and partial response PR in patients treated with this regimen
Determine the disease control rate CR PR and stable disease in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of sirolimus followed by a phase II study
Phase I Patients receive oral gefitinib once daily and oral sirolimus once daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive gefitinib and sirolimus as in phase I at the MTD Quality of life is assessed at baseline day 1 of each course and then at 1 month post-progression
Patients are followed every 9 weeks Patients withdrawn from study treatment without evidence of disease progression are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 25 patients 11 for phase I and 14 for phase II will be accrued for this study within 83 months
Primary
Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer
Secondary
Determine the overall response rate complete response CR and partial response PR in patients treated with this regimen
Determine the disease control rate CR PR and stable disease in patients treated with this regimen
Determine the time to progression and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is an open-label phase I dose-escalation study of sirolimus followed by a phase II study
Phase I Patients receive oral gefitinib once daily and oral sirolimus once daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive gefitinib and sirolimus as in phase I at the MTD Quality of life is assessed at baseline day 1 of each course and then at 1 month post-progression
Patients are followed every 9 weeks Patients withdrawn from study treatment without evidence of disease progression are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 25 patients 11 for phase I and 14 for phase II will be accrued for this study within 83 months
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 |
|---|---|---|---|
| ZENECA-IRUSIRES0281 | None | None | None |
| UCLA-0407057-01 | None | None | None |