Patients with UNOPERABLE NON NON SQUAMOUS NON SMALL CELL LUNG CANCER MedDRA version: 9.1 Level: LLT Classification code 10001160 Term: Adenocarcinoma lung
Conditions
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-squamous NSCLC. Age ≥ 18 years ECOG performance status 0-3 Life expectancy > 12 weeks Adequate hematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL INR ≤1.5 and PTT ≤1.5 x ULN within 7 days prior to starting study treatment Adequate liver function: serum bilirubin ≤1.5 x ULN; transaminases ≤2.5 x ULN (in case of liver metastatases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component History of hemoptysis, defined as bright red blood of at least half a teaspoon Brain metastases or spinal cord compression (CT or MRI of the head is required in symptomatic patients within 4 weeks prior to randomization) Evidence of tumor invading or abutting major blood vessels Surgery (including open biopsy), significant traumatic injury or radiotherapy within the last 4 weeks prior to first dose of study treatment or anticipation of the need for major surgery during study treatment Pregnant or lactating women Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment Known hypersensitivity to any of the study drugs Non healing wound, ulcer or bone fracture History of thrombotic hemorrhagic disorders Uncontrolled hypertension Clinically significant cardiovascular disease for example CVA (≤6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, NYHA ≥ grade 2 CHF, arrhythmia requiring medication Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325mg/day) or other NSAID with anti-platelet activity or treatment with dipyramidole, ticlopidine, clopidogrel and cilostazol Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the antitumoral activity and safety profile of three different dosages of Bevacizumab in association to a novel metronomic chemotherapic schedule mPE in terms of objective responses.;Secondary Objective: Assessment of time to progression and overall survival.;Primary end point(s): Primary endpoint: Assessment of the antitumoral activity and safety profile of three different dosages of Bevacizumab in association to a novel metronomic chemotherapic schedule mPE in terms of objective responses. Assessment of time to progression and overall survival. | — |
Countries
Italy
Outcome results
None listed