NCT00575640

Hydralazine as a Demethylating Agent in Rectal Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Hydralazine	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

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-05-01
• First posted: 2007-12-18
• Last updated: 2015-03-04