Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093626
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2004-10-06
Brief Title:
Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of BAY 43-9006 Sorafenib Nexavar NCI-Supplied Agent NSC 724772 in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
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:
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
II Determine 6-month progression-free survival of patients treated with this drug
III Determine the toxicity of this drug in terms of frequency and severity of adverse events encountered in these patients
SECONDARY OBJECTIVES
I Determine the clinical response rate partial and complete response in patients treated with this drug
II Determine the duration of progression-free and overall survival of patients treated with this drug
III Correlate prognostic variables platinum sensitivity performance status and histology clear cell and mucinous type with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral sorafenib 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 and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 22-60 patients will be accrued for this study within 6-13 months
I Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma
II Determine 6-month progression-free survival of patients treated with this drug
III Determine the toxicity of this drug in terms of frequency and severity of adverse events encountered in these patients
SECONDARY OBJECTIVES
I Determine the clinical response rate partial and complete response in patients treated with this drug
II Determine the duration of progression-free and overall survival of patients treated with this drug
III Correlate prognostic variables platinum sensitivity performance status and histology clear cell and mucinous type with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral sorafenib 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 and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 22-60 patients will be accrued for this study within 6-13 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02624 | REGISTRY | None | None |
| CDR0000389246 | None | None | None |
| GOG-0170F | OTHER | None | None |
| GOG-0170F | OTHER | None | None |