![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
University of Arkansas |
---|---|
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00575640 |
Clinically feasible dose of Hydralazine for ~ 3 months, by virtue of its demethylating effect, will:
Condition | Intervention | Phase |
---|---|---|
Rectal Cancer |
Drug: Hydralazine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Hydralazine as a Demethylating Agent in Rectal Cancer |
Estimated Enrollment: | 47 |
Study Start Date: | November 2004 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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 |
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
|
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.
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The principal objective of this study is to perform a molecular evaluation for the reversal of methylation in clinical material collected at two different time points. The first sample representing untreated (the biopsy sample), and later a hydralazine-treated specimen (the resection specimen).
Accordingly, we are not using routine inclusion criterion for enrollment (such as histology or clinical stage), but realize that the majority of operable rectal cancers will be stages II-III, and that treatment—again not specified or restricted—will very likely follow the standard therapy for this disease (infusional 5-Fluorouracil and radiation therapy). The accrual target at the phase II segment of this trial is small and that does not allow for any traditional clinical endpoints assessment (such as response rate, time to treatment failure or survival). Accordingly, we do not plan on following these endpoint as part of this study.
Patients referred to the surgery or gastroenterology services for diagnostic evaluation for rectal cancer will be candidates to participate in this study. Patients with history of elevated blood pressure and who are already on anti-hypertensive drugs would be ideal candidates for this project. In such situation, hydralazine will replace other anti-hypertensives for the duration of study only. There is no age limit for this study. Inclusion criteria are as follows:
Exclusion Criteria:
Coronary even in the preceding 2 months prior to enrollment. Coronary evens include any of the following:
Responsible Party: | University of Arkansas for Medical Sciences ( Ahmed M. Safar, MD ) |
Study ID Numbers: | 2004-03 |
Study First Received: | December 14, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00575640 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vasodilator Agents Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Hydralazine Rectal Neoplasm Cardiovascular Agents Intestinal Diseases |
Antihypertensive Agents Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Vasodilator Agents Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Hydralazine Cardiovascular Agents Intestinal Diseases Antihypertensive Agents Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |