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Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00466089
Recruitment Status : Unknown
Verified November 2007 by Hospital of Navarra.
Recruitment status was:  Recruiting
First Posted : April 27, 2007
Last Update Posted : January 10, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Erlotinib (Tarceva®) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
RT + Tarceva
Drug: Erlotinib (Tarceva®)
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
No Intervention: 2
RT


Outcome Measures

Primary Outcome Measures :
  1. To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).

Secondary Outcome Measures :
  1. The progression-free survival.
  2. 1-year survival.
  3. Overall survival.
  4. Objective response rate, according to RECIST criteria.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any specific procedure of the protocol.
  • Histologically confirmed diagnosis of non small cell lung cancer.
  • Unresectable (IA-IIIB) non-small cell lung cancer.
  • Patients non susceptible for chemotherapy treatment
  • Measurable disease according to RECIST criteria
  • Age > 18 years.
  • ECOG performance status < 2.
  • Adequate bone marrow, hepatic, renal and respiratory function.
  • Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up.
  • Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment.
  • Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy.
  • History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
  • Pregnant or lactating women.
  • Any other severe disease or clinical conditions, as, but not only:

    1. Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
    2. Uncontrolled active infection
    3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
    4. Autoimmune diseases.
  • Concomitant treatment with any other antineoplastic therapy.
  • Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
  • Prior treatment with EGFR targeted therapies.
  • Erlotinib known hypersensibility.
  • Any radiotherapy treatment contraindication.
  • History of significant neurological or psychiatric disorders, including epileptic seizures.
  • Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended)
  • Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
  • Any other underlying severe process affecting the ability to take part in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466089


Contacts
Contact: Enrique Martinez, Dr. 00 34 848 42 22 22 ext 2161 enrique.martinez.lopez@cfnavarra.es

Locations
Spain
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Enrique Martinez, Dr.         
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Principal Investigator: Nuria Viñolas, Dr.         
Principal Investigator: Francesc Casas, Dr.         
Hospital Puerta de Hierro Recruiting
Madrid, Spain, 28035
Principal Investigator: Alejandro De la Torre, Dr.         
Fundación Jimenez Diaz Recruiting
Madrid, Spain, 28040
Principal Investigator: Ana Mª Perez Casas, Dr.         
Hospital de Donostia Recruiting
San Sebastian, Spain, 20080
Principal Investigator: Julian Minguez, Dr.         
Sponsors and Collaborators
Hospital of Navarra
Dr. Enrique Martínez López
Investigators
Principal Investigator: Enrique Martínez, Dr. Hospital de Navarra
Principal Investigator: Ana Mª Perez Casas, Dr. Fundación Jimenez Diaz
Principal Investigator: Alejandro De la Torre, Dr. Hospital Puerta de Hierro
Principal Investigator: Francesc Casas, Dr. Hospital Clínic i Provincial de Barcelona
Principal Investigator: Nuria Viñolas, Dr. Hospital Clínic i Provincial de Barcelona
Principal Investigator: Julian Minguez, Dr. Hospital de Donostia
More Information

Responsible Party: Dr. Enrique Martínez López
ClinicalTrials.gov Identifier: NCT00466089     History of Changes
Other Study ID Numbers: MO19182
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: November 2007

Keywords provided by Hospital of Navarra:
NSCLC, lung cancer
Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action