Improving Tumor Oxygenation in Cervical Cancer

NCT ID: NCT00257829

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-09-20

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Methazolamide

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Chao Family Comprehensive Cancer Center

Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devansu Tewari, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Other Identifiers

UCI 03-41

Identifier Type: -

Identifier Source: org_study_id