Improving Tumor Oxygenation in Cervical Cancer

NCT00257829 | Withdrawn Phase 2 DMC

• 1 other identifier: UCI 03-41
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility in improving tumor oxygenation

Interventions

Methazolamide DRUG

Cisplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies
• A serum pregnancy test
• Detectable tumor will be measured.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Methazolamide; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Devansu Tewari, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cancer Center

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: July 1, 2004
• Primary Completion: September 20, 2006
• Study Completion: September 20, 2006
• Last Updated: December 3, 2018

Record last verified: 2018-11