Improving Tumor Oxygenation in Cervical Cancer

University of California Irvine (UCI)

Status and phase

Withdrawn

Phase 2

Conditions

Cervical Cancer

Treatments

Drug: Cisplatin

Drug: Methazolamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00257829

UCI 03-41

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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
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