Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041041
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2002-07-08
Brief Title:
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation Of Gleevec Imatinib Mesylate IND 61135 NSC 716051 In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the cytostatic anti-tumor activity of Gleevec Imatinib Mesylate through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec
II To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC
SECONDARY OBJECTIVES
I To determine the distribution of the overall survival II To determine the distribution of progression-free survival III To estimate the clinical response rate partial and complete response as defined under the RECIST criteria
IV To assess the effects of prognostic variables initial performance status platinum sensitivity and mucinous or clear cell histology
TERTIARY OBJECTIVES
I To determine the levels of expression of c-KIT and its ligand stem cell factor SCF in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
II To determine the levels of expression of platelet derived growth factor receptor PDGFR and its ligand PDGF in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
III To determine the levels of expression of AKT2 and its activated form phospho-AKT2 in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To evaluate the cytostatic anti-tumor activity of Gleevec Imatinib Mesylate through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec
II To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC
SECONDARY OBJECTIVES
I To determine the distribution of the overall survival II To determine the distribution of progression-free survival III To estimate the clinical response rate partial and complete response as defined under the RECIST criteria
IV To assess the effects of prognostic variables initial performance status platinum sensitivity and mucinous or clear cell histology
TERTIARY OBJECTIVES
I To determine the levels of expression of c-KIT and its ligand stem cell factor SCF in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
II To determine the levels of expression of platelet derived growth factor receptor PDGFR and its ligand PDGF in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
III To determine the levels of expression of AKT2 and its activated form phospho-AKT2 in archived formalin fixed paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000069438 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA027469 |
| GOG-0170E | None | None | None |
| U10CA027469 | NIH | None | None |