Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
The current standard for locally advanced cervical cancer is concurrent cisplatin-based
chemotherapy, however, the treatment results need to be improved. Epigenetic aberrations play
an important role in cancer progression by silencing growth regulatory genes and there is now
evidence that inhibitors of DNA methylation and HDAC inhibition synergize the radiation and
chemotherapy effects.
Objective. To determine response rate, safety and biological effects of hydralazine and
magnesium valproate when added to cisplatin chemoradiation.
Hypothesis. Hydralazine and magnesium valproate associated to chemoradiation will increase
the clinical complete response rate to 95% as compared to 75% as seen in historical controls
treated with cisplatin chemoradiation in FIGO stage IIIB patients.
Metodology. A total of 17 FIGO stage IIIB patients with histologically confirmed cervical
carcinoma with no previous treatment will be included. Patients will be typed for acetylator
status and and then receive either 182 or 83 mg of hydralazine, and magnesium valproate at
40mg/Kg from day -7 to the end of chemoradiation (external and brachytherapy). Clinical
response rate, safety and transcriptome changes will be analyzed.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Cancerología
Collaborators:
National Council of Science and Technology, Mexico Psicofarma S.A. de C.V.