Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039585
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-06-06
Brief Title:
Imatinib Mesylate in Treating Patients With Refractory or Relapsed Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer or Ovarian Low Malignant Potential Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate Gleevec STI571 A PDGFR And C-Kit Inhibitor In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer Fallopian Tube And Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial fallopian tube or primary peritoneal cancer or ovarian low malignant potential tumor
PURPOSE Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial fallopian tube or primary peritoneal cancer or ovarian low malignant potential tumor
Detailed Description:
OBJECTIVES
Determine the clinical activity of imatinib mesylate in patients with recurrent or relapsed ovarian epithelial fallopian tube or primary peritoneal cancer or ovarian low malignant potential tumor
Correlate the biochemical modulation of signal transduction pathways downstream of platelet-derived growth factor receptor PDGFR and c-kit tyrosine kinases in biopsy tissue with outcome in patients treated with this drug
Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue with response and outcome in patients treated with this drug
Investigate the potential antiangiogenic activity of this drug in microdissected tumor cell and stromal lysates of these patients
Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy tissue of patients treated with this drug
Evaluate the application of surface-enhanced laser desorption and ionization with time-of-flight detection SELDI-TOF with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response in these patients andor toxicity of this drug
OUTLINE Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Up to 47 patients will be accrued for this study within 12-20 months
Determine the clinical activity of imatinib mesylate in patients with recurrent or relapsed ovarian epithelial fallopian tube or primary peritoneal cancer or ovarian low malignant potential tumor
Correlate the biochemical modulation of signal transduction pathways downstream of platelet-derived growth factor receptor PDGFR and c-kit tyrosine kinases in biopsy tissue with outcome in patients treated with this drug
Correlate the expression of PDGFR and c-kit in both archival and fresh biopsy tissue with response and outcome in patients treated with this drug
Investigate the potential antiangiogenic activity of this drug in microdissected tumor cell and stromal lysates of these patients
Investigate the potential for collateral receptor tyrosine kinase inhibition in biopsy tissue of patients treated with this drug
Evaluate the application of surface-enhanced laser desorption and ionization with time-of-flight detection SELDI-TOF with artificial intelligence bioinformatics to serially obtained serum samples for prediction of response in these patients andor toxicity of this drug
OUTLINE Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Up to 47 patients will be accrued for this study within 12-20 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 |
|---|---|---|---|
| NCI-5672A | None | None | None |
| NCI-02-C-0190 | None | None | None |