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

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Velcade (bortezomib)
Irinotecan
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring advanced cervical cancer, metastatic cervical cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Sites / Locations

  • Women & Infants' Hospital

Outcomes

Primary Outcome Measures

overall response rate
time to progression

Secondary Outcome Measures

overall survival
toxicity of this combination in women with advanced cervical cancer

Full Information

First Posted
March 21, 2005
Last Updated
April 17, 2007
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00106262
Brief Title
Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
advanced cervical cancer, metastatic cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Velcade (bortezomib)
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Primary Outcome Measure Information:
Title
overall response rate
Title
time to progression
Secondary Outcome Measure Information:
Title
overall survival
Title
toxicity of this combination in women with advanced cervical cancer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don S Dizon, MD
Organizational Affiliation
Women & Infants' Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants' Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

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

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