Clinical trial NCT00466089: Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
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.
Lead sponsor: Hospital of Navarra
Sponsor class: OTHER
Collaborators: name: Dr. Enrique Martínez López
First posted: 2007-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary outcomes:
measure: The progression-free survival.
measure: 1-year survival.
measure: Overall survival.
measure: Objective response rate, according to RECIST criteria.
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Fundación Jimenez Diaz
city: San Sebastian
country: Spain
facility: Hospital de Donostia
Study officials:
affiliation: Hospital de Navarra
name: Enrique Martínez, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Jimenez Diaz
name: Ana Mª Perez Casas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro
name: Alejandro De la Torre, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic i Provincial de Barcelona
name: Francesc Casas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic i Provincial de Barcelona
name: Nuria Viñolas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Donostia
name: Julian Minguez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: