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

January 9, 2008 updated by: Hospital of Navarra

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial de Barcelona
        • Principal Investigator:
          • Nuria Viñolas, Dr.
        • Principal Investigator:
          • Francesc Casas, Dr.
      • Madrid, Spain, 28040
        • Recruiting
        • Fundación Jiménez Díaz
        • Principal Investigator:
          • Ana Mª Perez Casas, Dr.
      • Madrid, Spain, 28035
        • Recruiting
        • Hospital Puerta de Hierro
        • Principal Investigator:
          • Alejandro De la Torre, Dr.
      • San Sebastian, Spain, 20080
        • Recruiting
        • Hospital de Donostia
        • Principal Investigator:
          • Julian Minguez, Dr.
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Hospital De Navarra
        • Principal Investigator:
          • Enrique Martinez, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Overall survival.
The progression-free survival.
1-year survival.
Objective response rate, according to RECIST criteria.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of Navarra

Collaborators

Dr. Enrique Martínez López

Investigators

  • Principal Investigator: Enrique Martínez, Dr., Hospital De Navarra
  • Principal Investigator: Ana Mª Perez Casas, Dr., Fundación Jiménez Díaz
  • Principal Investigator: Alejandro De la Torre, Dr., Hospital Puerta de Hierro
  • Principal Investigator: Francesc Casas, Dr., Hospital Clinic i Provincial de Barcelona
  • Principal Investigator: Nuria Viñolas, Dr., Hospital Clinic i Provincial de Barcelona
  • Principal Investigator: Julian Minguez, Dr., Hospital de Donostia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 10, 2008

Last Update Submitted That Met QC Criteria

January 9, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO19182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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