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

Phase 2
18 Years
80 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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.

Inclusion Criteria

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not part of normal medical care, with the understanding that consent may be withdrawn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

- 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 mannitol.

- Female subject is pregnant or breast-feeding.

- Patient has received other investigational drugs with 14 days before enrollment

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Prior treatment with CAMPTOSAR or VELCADE

- More than one prior treatment for metastatic disease.

- Concurrent uncontrolled illness

- Ongoing or active infection

- History or active secondary cancer within the last 5 years, except for superficial
basal cell skin cancers

- Psychiatric illness or social situation that would preclude study compliance.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Principal Investigator

Don S Dizon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women & Infants' Hospital of Rhode Island


United States: Institutional Review Board

Study ID:




Start Date:

March 2005

Completion Date:

March 2007

Related Keywords:

  • Cervical Cancer
  • advanced cervical cancer
  • metastatic cervical cancer
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms



Women & Infants' Hospital Providence, Rhode Island  02905