Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Erlotinib (Tarceva®)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring NSCLC, lung cancer, Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.
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:
- 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 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.
Sites / Locations
- Hospital de NavarraRecruiting
- Hospital Clínic i Provincial de BarcelonaRecruiting
- Hospital Puerta de HierroRecruiting
- Fundación Jimenez DiazRecruiting
- Hospital de DonostiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
RT + Tarceva
RT
Outcomes
Primary Outcome Measures
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary Outcome Measures
The progression-free survival.
1-year survival.
Overall survival.
Objective response rate, according to RECIST criteria.
Full Information
NCT ID
NCT00466089
First Posted
April 25, 2007
Last Updated
January 9, 2008
Sponsor
Hospital of Navarra
Collaborators
Dr. Enrique Martínez López
1. Study Identification
Unique Protocol Identification Number
NCT00466089
Brief Title
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
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital of Navarra
Collaborators
Dr. Enrique Martínez López
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
RT + Tarceva
Arm Title
2
Arm Type
No Intervention
Arm Description
RT
Intervention Type
Drug
Intervention Name(s)
Erlotinib (Tarceva®)
Intervention Description
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
Primary Outcome Measure Information:
Title
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary Outcome Measure Information:
Title
The progression-free survival.
Title
1-year survival.
Title
Overall survival.
Title
Objective response rate, according to RECIST criteria.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Martinez, Dr.
Phone
00 34 848 42 22 22
Ext
2161
Email
enrique.martinez.lopez@cfnavarra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Martínez, Dr.
Organizational Affiliation
Hospital de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Mª Perez Casas, Dr.
Organizational Affiliation
Fundación Jimenez Diaz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alejandro De la Torre, Dr.
Organizational Affiliation
Hospital Puerta de Hierro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesc Casas, Dr.
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nuria Viñolas, Dr.
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julian Minguez, Dr.
Organizational Affiliation
Hospital de Donostia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Martinez, Dr.
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Viñolas, Dr.
First Name & Middle Initial & Last Name & Degree
Francesc Casas, Dr.
Facility Name
Hospital Puerta de Hierro
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro De la Torre, Dr.
Facility Name
Fundación Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Mª Perez Casas, Dr.
Facility Name
Hospital de Donostia
City
San Sebastian
ZIP/Postal Code
20080
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Minguez, Dr.
12. IPD Sharing Statement
Learn more about this trial
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
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