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

NCT00466089 | Unknown Phase 2

• 1 other identifier: MO19182
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, lung cancer; Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• The progression-free survival.

• 1-year survival.

• Overall survival.

• Objective response rate, according to RECIST criteria.

Study Arms (2)

1

EXPERIMENTAL

RT + Tarceva

Drug: Erlotinib (Tarceva®)

2

NO INTERVENTION

RT

Interventions

Erlotinib (Tarceva®) DRUG

Erlotinib (Tarceva®), 150mg/day p.o during 6 months.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
• Uncontrolled active infection
• Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
• Autoimmune diseases.
• Concomitant treatment with any other antineoplastic therapy.
• 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.

Sponsors & Collaborators

• Hospital of Navarra: lead
• Dr. Enrique Martínez López: collaborator

Study Sites (5)

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital Puerta de Hierro

Madrid, Madrid, 28035, Spain

RECRUITING

Fundación Jimenez Diaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital de Donostia

Donostia / San Sebastian, San Sebastian, 20080, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Martinez, Dr.

CONTACT

00 34 848 42 22 22; enrique.martinez.lopez@cfnavarra.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: March 1, 2006
• Last Updated: January 10, 2008

Record last verified: 2007-11

Locations

ES (5)