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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00466089
• Other study ID #: MO19182
• Status: Recruiting
• Phase: Phase 2
• First received: April 25, 2007
• Last updated: January 9, 2008
• Start date: March 2006

Study information

• Verified date: November 2007
• Source: Hospital of Navarra
• Contact: Enrique Martinez, Dr.
• Phone: 00 34 848 42 22 22
• Email: enrique.martinez.lopez[@]cfnavarra.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Fundación Jimenez Diaz	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital de Donostia	San Sebastian

Sponsors (2)

Lead Sponsor	Collaborator
Hospital of Navarra	Dr. Enrique Martínez López

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary	The progression-free survival.
Secondary	1-year survival.
Secondary	Overall survival.
Secondary	Objective response rate, according to RECIST criteria.