Metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not previously been treated with anticancer drugs
Conditions
Interventions
Trade Name: TARCEVA
Product Name: Tarceva
Product Code: RO 50-8231
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB
CAS Number: 183319-69-9
Concentration unit: mg milligram(s)
Co
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled. 2.Patients must have not previously been treated with anticancer drugs. 3.ECOG performance status of 0 - 1. 4.Life expectancy of at least 12 weeks. 5.Patients must be able to take oral medication. 6.At least 4 weeks since any prior surgery or radiotherapy. 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 7.Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin ³ 9.0g/dl. 8.SGOT (AST) and SGPT (ALT) 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be 60 ml/min. 11.Normal serum calcium. 12.For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.. 13.Patients with reproductive potential must use effective contraception. 14.Able to comply with study and follow-up procedures. 15.Written (signed) Informed Consent to participate in the study. 16.Written (signed) Informed Consent for use of tumour samples. 17.Patients must be able to effectively read, and understand the local language(s) for which Quality of Life rating scales are available. 18.Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzamab). 2.Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted. 3.Patients who have undergone complete tumour resection after responding to platinum based chemotherapy. 4.Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications. 5.Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). 6.Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded. 7.Patients who are at risk (in the investigator’s opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded. 8.Any inflammatory changes of the surface of the eye. 9.Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. 10.Nursing and/or pregnant women. 11.Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test erlotinib in combination with docetaxel for indications for synergy given intermittently prior or after the infusion of chemotherapy at recommended dose in patients with NSCLC by using progression free survival (PFS) as endpoint;Primary end point(s): To test erlotinib in combination with docetaxel for indications for synergy given intermittently prior or after the infusion of chemotherapy at recommended dose in patients with NSCLC by using progression free survival (PFS) as endpoint.;Secondary Objective: 1.To compare Objective Response Rate (ORR) and duration of response between the two treatment schedules (pre- or post chemotherapy) 2.To map expression of key cellular proteins that regulate EGFR driven biological processes (EGFR, HER2, ras, MAPK, Akt, PI3K) in initial tumor biopsy material 3.To monitor the effect of therapy on the expression of the same molecules on tumor specimens obtained in patients after a minimum 2 to 3 months 4.To investigate tolerability and safety of each of the trial schedules 5.To investigate for drug to drug pharmacokinetic interactions 6.To define the best dosing schema by terms of biological effects and clinical outcome | — |
Countries
Greece
Outcome results
None listed