A Phase II Study of VELCADE TM(PS-341) and Irinotecan in the Treatment of Progressive, Recurrent or Metastatic Cervical, Vulvar, or Vaginal Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
Don S Dizon, MD
Principal Investigator
Women & Infants' Hospital of Rhode Island
United States: Institutional Review Board
X05122
NCT00106262
March 2005
March 2007
Name | Location |
---|---|
Women & Infants' Hospital | Providence, Rhode Island 02905 |