An expanded access program of Tarceva (erlotinib) in patients with advanced stage IIIB/ IV non-small cell lung cancer (NSCLC)

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Diagnosis of small-cell lung cancer (stages IIIB or IV non-operable) recurrent or metastatic, locally advanced, documented by histology or cytology
• Patients must present evidence of illness but the presence of measurable disease is not mandatory.
• Age> 18 years
• Performance status (PS) according to ECOG of O - 3
• Life expectancy of at least 12 weeks
• Patients who have received at least one course of standard systemic chemotherapy or radiation therapy or who, in the opinion of the investigator, are not medically fit for chemotherapy or radiation therapy, or are not eligible for other studies with erlotinib.
• Patients who have not received more than 2 previous chemotherapy regimens.
• Patients should have recovered (CTC <1) from any acute toxic effects of any previous treatment and should have at least 3-4 weeks elapsed since the last dose of combination chemotherapy before inclusion (14 days for vinorelbine and other alkaloids). the vinca or gemcitabine as monodrogas).
• Patients who, in the opinion of the investigator, have recovered from the surgery in less than 4 weeks, may also be considered for the study.
• Granulocyte count> 1.5 x 10 ^ / L and platelet count> 100 x 10 ^ / L
• Serum bilirubin should be <1.5 of the upper normal limit of the reference range (LSRR).
• ASAT and / or ALAT <2 ULN (or <5 in each of which are clearly attributable to the presence of liver metastases)
• Serum creatinine <1.5 ULN or creatinine clearance> 60 ml / min.
• Patient capable of complying with the study and follow-up procedures.
• For all women with potential to have a family, a negative pregnancy test must be obtained within 72 hours before starting therapy.
• Patients with reproductive capacity should use efficient contraceptive methods.
• Written informed consent (signed) to participate in the study.

Exclusion Criteria

• Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, kidney or metabolic disease).
• Previous treatment with systemic antitumor therapy with HERl / EGFR inhibitors (both with small molecules and with monoclonal antibodies)
• Any other malignant pathology within the previous 5 years (except for in situ carcinoma of the cervix or skin cancer of basal or squamous cells adequately treated).
• Presence of CNS metastasis or spinal cord compression, recently diagnosed and / or not treated definitively with surgery and / or radiation; Patients with CNS metastasis or spinal cord compression previously diagnosed and treated (with images compatible with stable disease) are admitted for at least 2 months.
• Any significant ophthalmological abnormality, especially severe dry eye syndrome, dry keratoconjunctivitis, Sjogren´s syndrome, severe keratitis due to exposure and any other disorder that may increase the risk of corneal epithelial injury. The use of contact lenses during the study is not recommended. The decision to continue with the use of contact lenses should be discussed with the oncologist in charge of the patient´s treatment and the ophthalmologist.
• Patients who can not take oral medication, who require intravenous nutrition, who have undergone previous surgical procedures that affect absorption, or who present with peptic ulcer.
• Women in breastfeeding period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:EASs, adverse events leading to premature withdrawal, unforeseen AEs related to Tarceva, and Tarceva-related skin rash<br>Measure:Safety and tolerability<br>Timepoints:During treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation of signs and symptoms<br>Measure:Best response achieved (according to the researchers evaluation)<br>Timepoints:After treatment<br>;<br>Outcome name:Clinical evaluation of signs and symptoms<br>Measure:Time to progression (TTP)<br>Timepoints:After treatment<br>;<br>Outcome name:Clinical evaluation after finishing the treatment<br>Measure:Global survival<br>Timepoints:After treatment<br>

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