Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106262
Status:
TERMINATED
Last Update Posted:
2007-04-18
First Post:
2005-03-21
Brief Title:
Study of Velcade and Irinotecan in Advanced Cervical Vulvar or Vaginal Cancer
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
A Phase II Study of VELCADE TMPS-341 and Irinotecan in the Treatment of Progressive Recurrent or Metastatic Cervical Vulvar or Vaginal Cancer
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is conducting an evaluation of two chemotherapy drugs Velcade and Irinotecan in women with advanced recurrent or metastatic cervical cancer vaginal cancer or vulvar cancer Patients with cervical cancer may have received a platinum-containing treatment as systemic therapy without radiation but is not required
Detailed Description:
This is a phase 2 study Patients with advanced or metastatic histologically documented squamous cell carcinoma adenocarcinoma or adenosquamous cancers originating in the cervix vagina or vulva will be eligible Measurable disease by either clinical exam or radiography is also required Patients receiving cisplatin-based chemoradiation as definitive treatment for local disease will be eligible Patients must have no more than one prior platinum-based chemotherapy regimen in the metastatic setting Patients presenting with distant metastatic disease beyond the pelvis will be eligible as long as they are not eligible for a higher priority study
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