Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatment nitroglycerin
Phase phase 1
Sponsor University of Texas Southwestern Medical Center
Collaborator VA Office of Research and Development
Start date January 2011
End date March 2017
Trial size 24 participants
Trial identifier NCT01407107, STU 122010-172

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose escalation trial of Nitroglycerin
nitroglycerin
0.2mg/hr nitroglycerin transdermal patch daily

Primary Outcomes

Measure
Maximum tolerated dose (MTD)
time frame: 4-6 weeks

Secondary Outcomes

Measure
Pathological complete response (pCR)
time frame: Time of surgery (~ 6-9 wks) following the completion of neoadjuvant therapy

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer
Principal investigator Jonathan Dowell, MD
Description This is an open label, non-randomized, multi-cohort, dose escalation trial to evaluate the safety, tolerability, feasibility and maximum tolerated dose (MTD) of topical nitroglycerin in addition to 5-flourouracil and radiation therapy for neo-adjuvant treatment of, T3-T4 or clinically node positive, operable rectal cancer. Patients that would otherwise be eligible for concurrent neo-adjuvant chemotherapy with continuous infusion 5-FU, for locally advanced operable rectal cancer, will be assigned to 4 sequential cohorts of 4 different dose levels of nitro glycerin patches (0.2; 0.4; 0.6 and 0.8mg/hr). Each cohort will consist of 3 patients. All patients will receive radiation therapy, 45-50 Gy in 25-28 fractions to the pelvis along with continuous infusion 5-FU 225mg/M2 for the duration of the radiation therapy. The radiation therapy will be planned and delivered as per institutional standard of care for the Dallas VAMC radiation oncology department.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.