Status:
COMPLETED
Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer
Lead Sponsor:
National Institute of Cancerología
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Psicofarma, S.A. De C.V.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Eligible patients after signing informed consent will undergo study evaluation and then typed for acetylator phenotype before receive either 182 or 83 mg of hydralazine, and magnesium valproate at 30m...
Eligibility Criteria
Inclusion
- informed consent, histological diagnosis of cervical carcinoma (epidermoid, adenoesquamous and adenocarcinoma), clinical stage III B, untreated, aged 18-70 years, performance status 0-2 according to ECOG classification, and adequate liver, hematological and renal function, as defined by: hemoglobin \>10 g/L, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 mL/min; total bilirubin \< 1.5 upper normal limit value; no evidence of systemic disease or para-aortic lymph node involvement.
Exclusion
- History of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. Other exclusion criteria included uncontrolled systemic disease or infection.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00404326
Start Date
May 1 2005
End Date
November 1 2006
Last Update
November 28 2006
Active Locations (1)
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1
National Institute of Cancerologia
Mexico City, TLALPAN, Mexico, 14080