Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096486
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2004-11-09
Brief Title:
Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Trial of Fixed Doses of Daily Gefitinib With Escalating Doses of Daily RAD001 in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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 Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving gefitinib together with everolimus may kill more tumor cells
PURPOSE This phase III trial is studying the side effects best way to give and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects best way to give and best dose of giving gefitinib with everolimus and to see how well it works in treating patients with stage IIIB or stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of everolimus when administered with gefitinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer Phase I
Determine the efficacy of this regimen in these patients Phase II
Secondary
Assess the pharmacokinetics of everolimus alone and in combination with gefitinib in these patients Phase I
OUTLINE This is an open-label phase I dose-escalation study of everolimus followed by a phase II study
Phase I Patients receive oral everolimus once on day 1 Beginning on day 8 patients receive oral gefitinib once daily Beginning on day 22 patients receive oral everolimus once daily Both drugs are then given concurrently for the rest of the treatment Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
Phase II Patients receive oral everolimus at the MTD determined in phase I and oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Primary
Determine the maximum tolerated dose of everolimus when administered with gefitinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer Phase I
Determine the efficacy of this regimen in these patients Phase II
Secondary
Assess the pharmacokinetics of everolimus alone and in combination with gefitinib in these patients Phase I
OUTLINE This is an open-label phase I dose-escalation study of everolimus followed by a phase II study
Phase I Patients receive oral everolimus once on day 1 Beginning on day 8 patients receive oral gefitinib once daily Beginning on day 22 patients receive oral everolimus once daily Both drugs are then given concurrently for the rest of the treatment Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
Phase II Patients receive oral everolimus at the MTD determined in phase I and oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| MSKCC-04033 | None | None | None |