gilt docetaxel - non-small cell lung cancer

Conditions: Lung Neoplasms

Summary: primary objective: * to compare response rate between genotypic groups and control group. secondary objective: * to determine the safety, time to treatment failure and survival in control and genotypic arms.


Eligibility criteria:
inclusion criteria: patients must be/have: * histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix x); * unresectable metastatic (stage iv or iiib malignant pleural effusion) nsclc; * who performance status \< 2; * adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics: * hemoglobin \> or = 10g/dl and no blood cell transfusion within the previous 2 weeks; * absolute neutrophil count \> 2.0 10\^9 cells/l; * platelet count \> or = 100.10\^9 cells/l; * no evidence of myelodysplastic syndrome or abnormal bone marrow reserve; * creatinine \ or = 60 ml/min (real or calculated); * total bilirubin \< or = unl; * asat (sgot) and/or alat (sgpt) \< or = 1.5 x unl; * alkaline phosphatases \< or = 5 x unl; * serum calcium \< or = 1.1 x unl; * at least one measurable lesion; * previous surgery intervention (more than 30 days before inclusion in the study) is allowed but metastatic disease must be demonstrated; * previous radiotherapy is allowed if: * less or equal to 10% of bone marrow has been irradiated * end of radiotherapy 21 days or more prior to inclusion in the study; * patient has fully recovered from all toxic effects; * at least one of the measurable target lesions for evaluation of tumor response has not been irradiated; * the patient must be accessible for treatment and follow-up. the patient entered into this trial must be treated and followed up at the participating center; * life expectancy \> or = 12 weeks; * the initial diagnostic procedures should be performed during the 4 weeks prior to the randomization. exclusion criteria: * pregnant or lactating women (women of childbearing potential must use adequate contraception); * prior systemic chemotherapy or immunotherapy for nsclc, even as neoadjuvant or adjuvant therapy; * prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years; * history or clinical symptomatic brain or leptomeningeal metastases; * current peripheral neuropathy and neurohearing \> or = ncic-ctg grade 2 except if due to trauma; * other serious illness or medical condition, including: * congestive heart disease; prior myocardial infarction within 6 months; * history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent; * infection requiring i.v. antibiotics and tuberculosis under treatment ongoing at study entry; * untreated superior vena cava syndrome; * active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticotherapy such as herpes, herpes zoster, cirrhosis; * hypercalcemia requiring therapy; * preexisting ascitis and/or clinical significant pericardial effusion; * patients whose lesion(s) are assessable only by radionuclide scan; * history of allergy to drugs containing the excipient tween 80®; * concurrent treatment with other investigational drugs; * participation in a clinical trial of one or more investigational agents (i.e. antibiotic) or devices within 30 days of study entry. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.