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Improving Tumor Oxygenation in Cervical Cancer

This study has been withdrawn prior to enrollment.
(This study was closed due to lack of funding.)
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00257829
First received: November 21, 2005
Last updated: February 27, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention Phase
Cervical Cancer
 Drug: Methazolamide
Drug: Cisplatin
 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: Improving Tumor Oxygenation in Cervical Cancer With Methazolamide

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

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

Estimated Enrollment: 18
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257829

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

No publications provided

ClinicalTrials.gov Identifier: NCT00257829     History of Changes
Other Study ID Numbers: UCI 03-41
Study First Received: November 21, 2005
Last Updated: February 27, 2008
Health Authority: United States: Institutional Review Board

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
Cisplatin
Methazolamide
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013