Status:
TERMINATED
Hydralazine and Valproate Added to Chemotherapy for Breast Cancer
Lead Sponsor:
National Institute of Cancerología
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Psicofarma, S.A. De C.V.
Conditions:
Locally Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating h...
Detailed Description
Eligible patients after signing the informed consent and will undergo study evaluation and then typed for acetylator phenotype before being treated with hydralazine at 182 mg for rapid-, or 83 mg for ...
Eligibility Criteria
Inclusion
- Aged 18 and older; histologically proven invasive T2-3, N0-2, and M0 (stages IIB-IIIA) breast carcinoma; Eastern Cooperative Oncology Group performance status ≤2. Hematological function: Absolute leukocyte count ≥4,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL. Hepatic function: total bilirubin, aspartate amino transferase and alanine amino transferase \<1.5 the upper normal limit. Renal function: creatinine ≤1.2 mg/dL or a calculated creatinine clearance of ≥60 mL/min. Written informed consent.
Exclusion
- A history of allergy to sulphas, hydralazine, or magnesium 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. Pregnancy and breast-feeding. Uncontrolled systemic disease or infection.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00395655
Start Date
June 1 2005
End Date
August 1 2006
Last Update
November 3 2006
Active Locations (1)
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1
Instituto Nacional de Cancerologia
Mexico City, TLALPAN, Mexico, 14080