Spots Global Cancer Trial Database for Hydralazine as a Demethylating Agent in Rectal Cancer
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Trial Identification
Brief Title: Hydralazine as a Demethylating Agent in Rectal Cancer
Official Title: Hydralazine as a Demethylating Agent in Rectal Cancer
Study ID: NCT00575640
Conditions
Interventions
Study Description
Brief Summary: Clinically feasible dose of Hydralazine for \~ 3 months, by virtue of its demethylating effect, will: 1. Result in re-expression of epigenetically silenced TSGs in rectal cancer specimens. 2. Decrease the global methylation in primary cancer cells compared to pre-treatment
Detailed Description: This study will be conducted as a phase I/II clinical trial. In addition to determining the maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant chemotherapy in normotensive patients with rectal cancer. Once the phase I trial is successfully completed, the phase II trial to evaluate the efficacy of hydralazine in producing a demethylation effect will begin. This phase I/II trial will require between 31 to 47 patients to complete. ⢠Phase I Study The objective of this study is to determine the MTD for Hydralazine added to standard neoadjuvant chemotherapy for operable recta cancer. Four dose levels of hydralazine are planned: Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Ahmed M Safar, MD
Affiliation: University of Arkansas
Role: PRINCIPAL_INVESTIGATOR
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