Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether topical nitroglycerin in addition to 5-flourouracil and radiation therapy are effective in the treatment of operable rectal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

• Biopsy proven Rectal Adenocarcinoma

• Histological diagnosis of operable T3-4, or T1-4 node positive, M0 rectal adenocarcinoma using endorectal ultrasound and/or MRI in addition to Computed Tomography (CT) of the chest, abdomen and pelvis for pre-study staging Acceptable alternatives for systemic staging instead of CT chest , abdomen, pelvis are CT abdomen and pelvis plus a Chest X-ray or a PET/CT

• Ability to give informed consent and willingness to adhere to study protocol

• Age ≥ 18 years and otherwise eligible to receive medical care at the Dallas VA Medical Center.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

• Adequate hematological, hepatic and renal function defined as in protocol.

Exclusion Criteria:

• Any condition that would hamper informed consent or ability to comply with the study protocol

• Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, decompensated congestive-heart failure, myocardial infarction within the last six months or ventricular arrhythmias requiring medication.

• Pregnant and lactating women.

• Patients taking Phosphodiesterase - 5 inhibitors (e.g. Sildenafil, Vardenafil or Tadalafil) and is unable to stop for the duration of the chemoradiotherapy.