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

Locally Advanced Non Small-Cell Lung Canger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886405
• Other study ID #: CB332/08
• Secondary ID: INCAN/CC/162/08C
• Status: Recruiting
• Phase: Phase 2
• First received: April 21, 2009
• Last updated: April 21, 2009
• Start date: July 2006
• Est. completion date: January 2010

Study information

• Verified date: April 2009
• Source: National Institute of Cancerología
• Contact: Oscar A Rodriguez, MD
• Phone: (0155)56280400
• Email: ogar[@]servidor.unam.mx
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non Small-Cell Lung Canger

Intervention

Drug:
• Transdermal nitroglycerin
Transdermal nitroglycerin (25mg/day) during 5 days (2 days before and 3 days after chemotherapy) at the beginning of each chemotherapy cycle for a total of 4 cycles

Locations

Country	Name	City	State
Mexico	National Institute of Cancerología	Mexico city	Distrito federal

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression, over-all survival		5 years	No
Secondary	Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin		5 years	No