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

This study is currently recruiting participants.
Verified April 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01407107
First received: July 29, 2011
Last updated: April 4, 2014
Last verified: April 2014

July 29, 2011
April 4, 2014
January 2011
January 2015   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01407107 on ClinicalTrials.gov Archive Site
Pathological complete response (pCR) [ Time Frame: Time of surgery (~ 6-9 wks) following the completion of neoadjuvant therapy ] [ Designated as safety issue: No ]
pathological complete response (pCR) at time of surgery following the completion of neoadjuvant therapy. This will be compared to the institutional historical pCR rate.
Same as current
Not Provided
Not Provided
 
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Phase I Dose Escalation Trial of Nitroglycerin in Addition to 5-flourouracil and Radiation Therapy for Neo-adjuvant Treatment of Operable Rectal Cancer

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
Drug: nitroglycerin
0.2mg/hr nitroglycerin transdermal patch daily
Active Comparator: Nitroglycerin
Dose escalation trial of Nitroglycerin
Intervention: Drug: nitroglycerin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Not Provided
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Sharjeel Farooqui 214-857-4237 sharjeely.farooqui@va.gov
United States
 
NCT01407107
VA10-100
Yes
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Department of Veterans Affairs
Principal Investigator: Henrik Illum, MD Dallas Veterans Affairs Medical Center
University of Texas Southwestern Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP