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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Cancerología.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT00886405
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Locally Advanced Non Small-Cell Lung Canger
 Drug: Transdermal nitroglycerin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • Time to progression, over-all survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2006
Estimated Study Completion Date: January 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nytroglicerin 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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886405

Contacts
Contact: Oscar A Rodriguez, MD (0155)56280400 ext 832 ogar@servidor.unam.mx

Locations
Mexico
National Institute of Cancerología Recruiting
Mexico city, Distrito federal, Mexico
Principal Investigator: Oscar A Rodriguez, MD            
Sponsors and Collaborators
National Institute of Cancerología
Investigators
Principal Investigator: Oscar A Rodriguez, MD National Counsil of Science and Technology
  More Information

No publications provided

Responsible Party: Oscar Arrieta Rodríguez, CONACYT
ClinicalTrials.gov Identifier: NCT00886405     History of Changes
Other Study ID Numbers: CB332/08, INCAN/CC/162/08, CA.030/CB332/08
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: Mexico: National Council of Science and Technology

Keywords provided by National Institute of Cancerología:
Nitroglycerin
Locally advanced non small-cell lung cancer
Vascular endothelial growth factor
Hypoxia Inducible Factor
Clinical stage IIIA and/or IIIB (without pleural effusion)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013