Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075400
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2004-01-09
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of GleevecTM NCI-Supplied Agent STI571 Imatinib Mesylate NSC 716051 in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the activity of Gleevectrademark TM imatinib mesylate as measured by progression-free survival at six months
II To determine the frequency and severity of adverse effects of GleevecTM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events version 30 CTCAE v30
SECONDARY OBJECTIVES
I To determine the distribution of progression-free survival and overall survival
II To estimate the objective response rate partial and complete response as defined under the Response Evaluation Criteria In Solid Tumors RECIST criteria
III To determine the effects of prognostic factors such as initial performance status and histological grade
TERTIARY OBJECTIVES
I To determine the levels of expression of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog c-KIT platelet-derived growth factor receptor PDGFR v-akt murine thymoma viral oncogene homolog 2 AKT2 and phosphorylated p-AKT2 in archived formalin-fixed paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy
OUTLINE
Patients receive imatinib mesylate orally PO once daily QD or twice daily BID on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I To determine the activity of Gleevectrademark TM imatinib mesylate as measured by progression-free survival at six months
II To determine the frequency and severity of adverse effects of GleevecTM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Events version 30 CTCAE v30
SECONDARY OBJECTIVES
I To determine the distribution of progression-free survival and overall survival
II To estimate the objective response rate partial and complete response as defined under the Response Evaluation Criteria In Solid Tumors RECIST criteria
III To determine the effects of prognostic factors such as initial performance status and histological grade
TERTIARY OBJECTIVES
I To determine the levels of expression of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog c-KIT platelet-derived growth factor receptor PDGFR v-akt murine thymoma viral oncogene homolog 2 AKT2 and phosphorylated p-AKT2 in archived formalin-fixed paraffin-embedded primary tumors collected prior to the initiation of first-line chemotherapy
OUTLINE
Patients receive imatinib mesylate orally PO once daily QD or twice daily BID on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2014-00653 | REGISTRY | None | None |
| CDR0000346361 | None | None | None |
| GOG-0230C | OTHER | None | None |
| GOG-0230C | OTHER | None | None |