Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers
- Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in
patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy.
- Evaluate the influence of treatment on the expression of mRNA codons in HPV
oncoproteins E6 and E7.
- Determine the rate of local control.
OUTLINE: This is a dose-escalation study of cidofovir.
Patients receive cidofovir IV weekly for 2 weeks prior to beginning radiotherapy and then
once biweekly during radiotherapy. Patients undergo external pelvic radiotherapy for 5
weeks. Beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. Some
patients may also undergo a second course of external radiotherapy to the parametrium and/or
lymph nodes ≤ 3 days after brachytherapy. Patients also receive concurrent carboplatin IV
once weekly during external radiotherapy and brachytherapy.
Biological expression of HPV oncoproteins E6 and E7 is analyzed during treatment.
Primary Purpose: Treatment
Maximum tolerated dose of cidofovir
Eric Deutsch, MD
Gustave Roussy, Cancer Campus, Grand Paris