Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263822
Status:
COMPLETED
Last Update Posted:
2013-08-27
First Post:
2005-12-07
Brief Title:
Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer Peritoneal Cancer or Fallopian Tube Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Multicenter Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Sometimes after treatment the tumor may not need additional treatment until it progresses In this case observation may be sufficient It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer peritoneal cancer or fallopian tube cancer
PURPOSE This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer peritoneal cancer or fallopian tube cancer
PURPOSE This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES
Primary
Compare the benefits in terms of progression-free survival of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after first-line platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian epithelial primary peritoneal or fallopian tube cancer
Secondary
Compare the overall survival of patients treated with these regimens
Determine the safety of erlotinib in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage I-II vs III-IV participating center age 65 vs 65 response to first-line therapy no evidence of diseasecomplete response vs partial response vs stable disease and first-line therapy platinum-based vs platinumtaxane combination vs platinum-based triplet Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral erlotinib once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation as per standard of care Quality of life is assessed at baseline and then every 3 months for up to 2 years
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 830 patients will be accrued for this study
Primary
Compare the benefits in terms of progression-free survival of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after first-line platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian epithelial primary peritoneal or fallopian tube cancer
Secondary
Compare the overall survival of patients treated with these regimens
Determine the safety of erlotinib in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage I-II vs III-IV participating center age 65 vs 65 response to first-line therapy no evidence of diseasecomplete response vs partial response vs stable disease and first-line therapy platinum-based vs platinumtaxane combination vs platinum-based triplet Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral erlotinib once daily for up to 2 years in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation as per standard of care Quality of life is assessed at baseline and then every 3 months for up to 2 years
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 830 patients will be accrued for this study
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 |
|---|---|---|---|
| EUDRACT-2004-004333-34 | None | None | None |
| EORTC-55041 | None | None | None |