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Improving Tumor Oxygenation in Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Methazolamide
Cisplatin
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical Cancer

Eligibility Criteria

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

Inclusion Criteria: The subject will have a malignant tumor of the cervix which is not curable by surgery in which it has been determined the subject is to receive the standard care of treatment of radiation therapy and chemotherapy. The subject must have adequate bone marrow function, renal function, hepatic function and neurologic function. The subject should be free of active infection requiring antibiotics. The subject must have signed the approved informed consent If the subject is of childbearing age, they must have a negative urine pregnancy test with effective contraception The subject must have met pre-entry requirements Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies A serum pregnancy test Detectable tumor will be measured. Exclusion Criteria: The subject has not been clinically staged for their cancer The subject has evidence of or is being treated for an active infection The subject cannot perform the appropriate follow-up or complete the study for whatever reason. The subject has not consented to an additional tumor biopsy and MRI after my seven days of treatment with methazolamide The subject has evidence of chronic obstructive pulmonary disease The subject is currently breastfeeding The subject is pregnant The subject takes aspirin chronically The subject has a history of Stevens-Johnson syndrome The subject has not signed the approved informed consent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To assess the feasibility in improving tumor oxygenation

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2005
    Last Updated
    November 29, 2018
    Sponsor
    University of California, Irvine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00257829
    Brief Title
    Improving Tumor Oxygenation in Cervical Cancer
    Official Title
    Improving Tumor Oxygenation in Cervical Cancer With Methazolamide
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    This study was closed due to lack of funding.
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    September 20, 2006 (Actual)
    Study Completion Date
    September 20, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The Phenomenon of Tumor Hypoxia Many solid tumors are relatively resistant to treatment with ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are affected adversely by acidic pH. These effects have primarily been attributed to the presence of hypoxic cells within the tumor. The relevance of hypoxia with respect to failure of radiotherapy to cure certain malignancies has had a chequered history. However, in recent years the evidence that hypoxia plays a central role in relative radioresistance has become more compelling. Since approximately two-thirds of all women suffering from cervical carcinoma receive radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation resistance is critical to improving outcome among those with cervical cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Methazolamide
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Primary Outcome Measure Information:
    Title
    To assess the feasibility in improving tumor oxygenation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The subject will have a malignant tumor of the cervix which is not curable by surgery in which it has been determined the subject is to receive the standard care of treatment of radiation therapy and chemotherapy. The subject must have adequate bone marrow function, renal function, hepatic function and neurologic function. The subject should be free of active infection requiring antibiotics. The subject must have signed the approved informed consent If the subject is of childbearing age, they must have a negative urine pregnancy test with effective contraception The subject must have met pre-entry requirements Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies A serum pregnancy test Detectable tumor will be measured. Exclusion Criteria: The subject has not been clinically staged for their cancer The subject has evidence of or is being treated for an active infection The subject cannot perform the appropriate follow-up or complete the study for whatever reason. The subject has not consented to an additional tumor biopsy and MRI after my seven days of treatment with methazolamide The subject has evidence of chronic obstructive pulmonary disease The subject is currently breastfeeding The subject is pregnant The subject takes aspirin chronically The subject has a history of Stevens-Johnson syndrome The subject has not signed the approved informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Devansu Tewari, MD
    Organizational Affiliation
    Chao Family Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Improving Tumor Oxygenation in Cervical Cancer

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