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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

Rectal Cancer

Interventions

Hydralazine

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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