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

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: nitroglycerin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Jonathan Dowell, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center

Overall contact:
Sharjeel Farooqui, Phone: 214-857-4237, Email: sharjeely.farooqui@va.gov


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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose (MTD)

Secondary outcome: Pathological complete response (pCR)

Detailed 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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Sharjeel Farooqui, Phone: 214-857-4237, Email: sharjeely.farooqui@va.gov

Dallas Veterans Affairs Medical Center, Dallas, Texas 75216, United States; Recruiting
Sharjeel Farooqui, Phone: 214-857-4237, Email: sharjeely.farooqui@va.gov
Henrik Illum, MD, Principal Investigator
Additional Information

Starting date: January 2011
Last updated: April 3, 2015

Page last updated: August 23, 2015

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