Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023712
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2001-09-13
Brief Title:
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Bortezomib Velcade PS-341 NSC 681239 IND 58443 in the Treatment of Persistent or Recurrent Platinum-Sensitive Epithelial Ovarian or Primary Peritoneal Cancer
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:
Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive bortezomib IV twice weekly for 2 weeks Courses repeat every 3 weeks 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 Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive bortezomib IV twice weekly for 2 weeks Courses repeat every 3 weeks 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02404 | REGISTRY | None | None |
| CDR0000068853 | None | None | None |
| GOG-0146N | None | None | None |
| GOG 0146N | OTHER | None | None |
| GOG-0146N | OTHER | None | None |