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Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106262
Recruitment Status : Terminated (Lack of accrual)
First Posted : March 22, 2005
Last Update Posted : April 18, 2007
Millennium Pharmaceuticals, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Velcade (bortezomib) Drug: Irinotecan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. overall response rate
  2. time to progression

Secondary Outcome Measures :
  1. overall survival
  2. toxicity of this combination in women with advanced cervical cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106262

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United States, Rhode Island
Women & Infants' Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Millennium Pharmaceuticals, Inc.
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Principal Investigator: Don S Dizon, MD Women & Infants' Hospital of Rhode Island
Layout table for additonal information Identifier: NCT00106262    
Other Study ID Numbers: X05122
First Posted: March 22, 2005    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007
Keywords provided by Women and Infants Hospital of Rhode Island:
advanced cervical cancer
metastatic cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Vaginal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents