Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

Condition(s) targeted: Locally Advanced Non Small-Cell Lung Canger

Intervention: Transdermal nitroglycerin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute of Cancerología

Official(s) and/or principal investigator(s):
Oscar A Rodriguez, MD, Principal Investigator, Affiliation: National Counsil of Science and Technology

Overall contact:
Oscar A Rodriguez, MD, Phone: (0155)56280400, Ext: 832, Email: ogar@servidor.unam.mx

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

Official title: Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to progression, over-all survival

Secondary outcome: Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Oscar A Rodriguez, MD, Phone: (0155)56280400, Ext: 832, Email: ogar@servidor.unam.mx

National Institute of Cancerología, Mexico city, Distrito federal, Mexico; Recruiting
Oscar A Rodriguez, MD, Principal Investigator

Starting date: July 2006
Last updated: April 21, 2009