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Sponsors and Collaborators: |
Women and Infants Hospital of Rhode Island Millennium Pharmaceuticals |
Information provided by: | Women and Infants Hospital of Rhode Island |
ClinicalTrials.gov Identifier: | NCT00106262 |
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.
Condition | Intervention | Phase |
Cervical Cancer |
Drug: Velcade (bortezomib) Drug: Irinotecan |
Phase II |
MedlinePlus related topics: | Cancer Cervical Cancer Vaginal Cancer |
ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of VELCADE TM(PS-341) and Irinotecan in the Treatment of Progressive, Recurrent or Metastatic Cervical, Vulvar, or Vaginal Cancer |
Estimated Enrollment: | 38 |
Study Start Date: | March 2005 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Rhode Island | |||||
Women & Infants' Hospital | |||||
Providence, Rhode Island, United States, 02905 |
Women and Infants Hospital of Rhode Island |
Millennium Pharmaceuticals |
Principal Investigator: | Don S Dizon, MD | Women & Infants' Hospital of Rhode Island |
Study ID Numbers: | X05122 |
First Received: | March 21, 2005 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00106262 |
Health Authority: | United States: Institutional Review Board |
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