Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer
18 Years
90 Years
Both
Rectal Cancer
Trial Information
Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD)
Outcome Description:
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.
Outcome Time Frame:
4-6 weeks
Safety Issue:
Yes
Principal Investigator
Henrik Illum, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dallas Veterans Affairs Medical Center
Authority:
United States: Institutional Review Board
Study ID:
VA10-100
NCT ID:
NCT01407107
Start Date:
January 2011
Completion Date:
Related Keywords:
- Rectal Cancer
- nitroglycerin
- 5-flourouracil
- radiation therapy
- neo-adjuvant treatment
- Rectal Neoplasms
Name | Location |
|---|---|
| Dallas Veterans Affairs Medical Center | Dallas, Texas 75216 |
