The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial
Status:
Completed
Trial end date:
2021-01-12
Target enrollment:
Participant gender:
Summary
Cervical cancer remains an important health problem worldwide. Poor tumor oxygenation
(hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation
treatment. Hypoxia-modifying therapies improve survival, but existing therapies are
impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to
decrease tumor hypoxia in animal studies and its use is associated with better survival in
diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor
hypoxia and thereby improve tumor response to radiation and survival in patients with locally
advanced cervix cancer.
This is a randomized, multicenter phase II study of standard chemoradiation in combination
with metformin versus standard chemoradiation alone in women with locally advanced cervix
cancer. Women randomized to the metformin group will take metformin starting 1 week prior to
standard chemoradiation and throughout the duration of external radiation treatment. Tumor
hypoxia will be measured by a special X-ray test called positron emission test (PET)
performed with a hypoxia dye called FAZA. The main purpose of this study is to see if
metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side
effects will also be collected.