An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as
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Full eligibility criteria for NCT01320501
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
Patients must have evidence of disease but measurable disease is not mandatory.
18 years of age or older.
ECOG performance status of 0 - 3.
Life expectancy of at least 12 weeks.
Patients who received one or two previous line of systemic chemotherapy irrespective of EGFR mutation status.
No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
Patients are eligible to receive Erlotinib (TarcevaTM) as first line if they met one of the following criteria:
Positive EGFR mutation tested in certified lab (although EGFR test is not mandatory only if available).
Poor performance status of 3
Severe co morbidities and illness which make the patient not candidate for standard systemic chemotherapy .
.Patient with negative EGFR mutation are still candidate for 2nd and 3rd line therapy
(although EGFR test is not mandatory only if available).
Prior radiotherapy is allowed.
Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L.
Serum bilirubin must be < 1.5 upper limit of normal (ULN).
AST and ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis).
Able to comply with study and follow-up procedures.
For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. Patients with reproductive potential must use effective contraception.
Signed Informed Consent to participate in the study.
Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and the ophthalmologist.
Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
All locations for NCT01320501
Saudi Arabia (1)
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, Saudi Arabia, 11426
View full eligibility
Tris trial is registered with FDA with number: NCT01320501. The sponsor of the trial is National Guard Health Affairs and it is looking for 100 volunteers for the current phase.
Official trial title: Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)
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