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

April 21, 2009
April 21, 2009
July 2006
April 2009   (final data collection date for primary outcome measure)
Time to progression, over-all survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer

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

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

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Non Small-Cell Lung Canger
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
Experimental: Nytroglicerin
Intervention: Drug: Transdermal nitroglycerin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2010
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Oscar A Rodriguez, MD (0155)56280400 ext 832 ogar@servidor.unam.mx
Mexico
 
NCT00886405
CB332/08, INCAN/CC/162/08, CA.030/CB332/08
No
Oscar Arrieta Rodríguez, CONACYT
National Institute of Cancerología
Not Provided
Principal Investigator: Oscar A Rodriguez, MD National Counsil of Science and Technology
National Institute of Cancerología
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP