Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510653
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2007-07-31
Brief Title:
Gleevec Study for Patients With Ovarian Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant Taxane-Resistant Epithelial Ovarian Cancer Primary Peritoneal Cancer or Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Primary Objectives
1 To determine the efficacy of Gleevec in patients with recurrent platinum-resistant taxane-resistant epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer whose tumor expresses either c-KIT platelet-derived growth factor receptor PDGRF or ABL
2 To determine the nature and degree of toxicity of Gleevec in this cohort of patients
1 To determine the efficacy of Gleevec in patients with recurrent platinum-resistant taxane-resistant epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer whose tumor expresses either c-KIT platelet-derived growth factor receptor PDGRF or ABL
2 To determine the nature and degree of toxicity of Gleevec in this cohort of patients
Detailed Description:
Imatinib Mesylate is a new medication that blocks several proteins important in the development of cancer Before going on study potential participants will have their tumor tested for c-KIT PDGFR and ABL for positivity Those participants who have at least one positive biomarker will be eligible for treatment
Before treatment starts participants will have a complete checkup blood tests chest x-ray and heart function test Women able to have children must have a negative blood pregnancy test A blood sample 3 teaspoons will be taken once a week during treatment and at the end of treatment A complete exam will also be done at the end of treatment Tumors will be measured by computed tomography CT scan every 6 weeks while one study and at the end of treatment
Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily basis Participants will be treated for 6 weeks which is one cycle of therapy After 6 weeks participants will be evaluated for side effects and tumor response The dose may be decreased for the next cycle if participants side effects Participants will be removed from the study if the tumor gets worse Participants may remain on the study as long as the tumor has not gotten worse and there are no intolerable side effects
This is an investigational study Imatinib Mesylate has been approved for chronic myelogenous leukemia patients However this is an investigational study of Imatinib Mesylate in patients with ovarian tubal or peritoneal cancer Participants may responsible for the cost of all or part of this drug At least 24 and as many as 74 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts participants will have a complete checkup blood tests chest x-ray and heart function test Women able to have children must have a negative blood pregnancy test A blood sample 3 teaspoons will be taken once a week during treatment and at the end of treatment A complete exam will also be done at the end of treatment Tumors will be measured by computed tomography CT scan every 6 weeks while one study and at the end of treatment
Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily basis Participants will be treated for 6 weeks which is one cycle of therapy After 6 weeks participants will be evaluated for side effects and tumor response The dose may be decreased for the next cycle if participants side effects Participants will be removed from the study if the tumor gets worse Participants may remain on the study as long as the tumor has not gotten worse and there are no intolerable side effects
This is an investigational study Imatinib Mesylate has been approved for chronic myelogenous leukemia patients However this is an investigational study of Imatinib Mesylate in patients with ovarian tubal or peritoneal cancer Participants may responsible for the cost of all or part of this drug At least 24 and as many as 74 patients will take part in this study All will be enrolled at M D Anderson
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