Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT00106262
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method overall response rate time to progression
- Secondary Outcome Measures
Name Time Method toxicity of this combination in women with advanced cervical cancer overall survival
Trial Locations
- Locations (1)
Women & Infants' Hospital
🇺🇸Providence, Rhode Island, United States
Women & Infants' Hospital🇺🇸Providence, Rhode Island, United States