NCT00106262

Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer

A Phase II Study of VELCADE TM(PS-341) and Irinotecan in the Treatment of Progressive, Recurrent or Metastatic Cervical, Vulvar, or Vaginal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (planned)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Velcade (bortezomib)
DRUG	Irinotecan

Timeline

• Start date: 2005-03-01
• Completion: 2007-03-01
• First posted: 2005-03-22
• Last updated: 2007-04-18

Locations

1 site across 1 country: United States