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Improving Tumor Oxygenation in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00257829
Recruitment Status : Withdrawn (This study was closed due to lack of funding.)
First Posted : November 23, 2005
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Methazolamide Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Tumor Oxygenation in Cervical Cancer With Methazolamide
Study Start Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the feasibility in improving tumor oxygenation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

    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

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 ClinicalTrials.gov identifier (NCT number): NCT00257829


Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Devansu Tewari, MD Chao Family Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00257829     History of Changes
Other Study ID Numbers: UCI 03-41
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by University of California, Irvine:
Cervical Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Methazolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs