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

This study has been terminated.
(Lack of accrual)
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00106262
First received: March 21, 2005
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • overall response rate
  • time to progression

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

Estimated Enrollment: 38
Study Start Date: March 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106262

Locations
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.
Investigators
Principal Investigator: Don S Dizon, MD Women & Infants' Hospital of Rhode Island
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00106262     History of Changes
Other Study ID Numbers: X05122
Study First Received: March 21, 2005
Last Updated: April 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
advanced cervical cancer
metastatic cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Vaginal Diseases
Bortezomib
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014