Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01407107|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: nitroglycerin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2011|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Dose escalation trial of Nitroglycerin
0.2mg/hr nitroglycerin transdermal patch daily
- Maximum tolerated dose (MTD) [ Time Frame: 4-6 weeks ]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.
- Pathological complete response (pCR) [ Time Frame: Time of surgery (~ 6-9 wks) following the completion of neoadjuvant therapy ]pathological complete response (pCR) at time of surgery following the completion of neoadjuvant therapy. This will be compared to the institutional historical pCR rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407107
|United States, Texas|
|Dallas Veterans Affairs Medical Center|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Jonathan Dowell, MD||UT Southwestern Medical Center|