Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Conditions
Locally Advanced Non Small-Cell Lung Canger
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Nitroglycerin, Locally advanced non small-cell lung cancer, Vascular endothelial growth factor, Hypoxia Inducible Factor, Clinical stage IIIA and/or IIIB (without pleural effusion)
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Transdermal nitroglycerin
Type: Drug
Overall Status
Recruiting
Summary
Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC
Detailed Description
Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histopathologic diagnosis of non small-cell lung cancer

- Clinical stage IIIA and/or IIIB without pleural effusion

- ECOG functional status 0 or 1

- No renal function alteration (GFR >50%)

- No hepatic function alteration (ALT and AST less than 2 times its normal value)

- Leucocytes more than 2,000/mcl

- Hemoglobin more than 10mg/dL

- Platelets more than 100,000/mcl

Exclusion Criteria:

- Ischemic heart disease

- Abnormal electrocardiogram
Location
National Institute of Cancerología
Mexico city, Distrito federal, Mexico
Status: Recruiting
Start Date
July 2006
Completion Date
January 2010
Sponsors
National Institute of Cancerología
Source
National Institute of Cancerología
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page