An open label study to evaluate the effect of first line treatment with Tarceva in combination with Gemcitabine on disease progression in patients with unresectable advanced and/or metastatic non-small cell lung cancer
- Conditions
- unresectable, advanced and/or metastatic non-small cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-002135-83-RO
- Lead Sponsor
- Roche Romania SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Histological or cytological documented diagnosis of advanced and/or metastatic (stage IIIB/ IV) chemotherapy-naive, unresectable, non-small cell lung cancer (NSCLC)
•Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria
•18 years of age or older
•ECOG performance status >/= 2
•Life expectancy of at least 12 weeks.
•Patients with advanced stage IIIB /IV NSCLC who did not received any course of standard systemic chemotherapy or radiation therapy or immunotherapy.
•Patients who, in the opinion of the investigator, are not suitable for surgery.Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
•Patients must have prescription for Gemcitabine 1000mg/m² iv D1, D8, D15 (q28) at the time of study enrollment.
•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/or ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis
•Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min
•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
•Written (signed) Informed Consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•Any active, non-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
•Prior therapy with systemic anti-tumour 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, Sjögren 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.
•Nursing mothers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate time to disease progression (TTP) and pathological response rate (CR, PR) according to RECIST criteria<br>;Secondary Objective: - To evaluate median and overall survival (OS)<br>- To evaluate safety profile in first line setting of Tarceva (erlotinib) 150mg po daily plus Gemcitabine 1000mg/m² iv D1, D8, D15 until disease progresion (PD), unacceptable toxicity, withdrawal due to any reason or death.<br>;Primary end point(s): •To evaluate time to disease progression (TTP) and <br>•Response rate (CR, PR) according to RECIST criteria<br>;Timepoint(s) of evaluation of this end point: 26 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •To evaluate median overall survival (OS)<br>•To evaluate safety profile in first line setting of Tarceva (erlotinib) 150 mg po daily plus Gemcitabine 1000mg/m² iv D1, D8, D15 for 6 cycles or until disease progression (PD), unacceptable toxicity, withdrawal due to any reason or death.<br>;Timepoint(s) of evaluation of this end point: 20 months