Improving Tumor Oxygenation in Cervical Cancer

November 29, 2018 updated by: Chao Family Comprehensive Cancer Center, University of California, Irvine

Improving Tumor Oxygenation in Cervical Cancer With Methazolamide

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

    1. Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies
    2. A serum pregnancy test
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the feasibility in improving tumor oxygenation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Devansu Tewari, MD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

September 20, 2006

Study Completion (Actual)

September 20, 2006

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 23, 2005

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCI 03-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe