Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer (NCT00106262) | Clinical Trial Compass
TerminatedPhase 2
Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer
Stopped: Lack of accrual
United States38 participantsStarted 2005-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* age \> 18
* Karnofsky performance status \> 60%
* Measurable disease on clinical exam or by RECIST criteria
* One prior platinum-based systemic chemotherapy regimen for advanced disease is allowed but not required. Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen and is also allowed. Patients eligible for a higher priority study will be excluded.
* Life expectancy \> 6 weeks
* Peripheral neuropathy ≤ Grade 2 by CTC 3.0 criteria
* Women of child-bearing potential must have a negative pregnancy test
* Adequate hematopoietic function defined as: ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.
* Adequate renal and hepatic function defined as: Bilirubin ≤ 1.5 times upper limit of normal (ULN); SGOT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; Creatinine ≤ 2 times ULN.
Exclusion Criteria
* Patient has hypersensitivity to bortezomib, boron or…