Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
docetaxel + bevacizumab
pemetrexed + bevacizumab
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous, non-small cell lung cancer 2)Clinical stage IIIB(not amenable to curative radiation),VI or recurrent disease 3)ECOG performance status 0-1 4)Patients who have at least one or more measurable lesion by RESIST(Version1.1) 5)Aged 75<= 6)Adequate organ funcution 7)Interval (1)Radiation therapy More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis resion (2)Operation More than 4 weeks after the last operation More than 2 weeks after the last pleurodesis or thoracic cavity drainage. More than 8 weeks after the last operation with brain metastasis 8)Estimated life expectancy at least 12 weeks 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 12 weeks prior to registration 2)Symptomatic brain metastasis 3)Current or recent(within 10 days prior to first dose of bevacizumab) use of aspirin(>325mg/day), clopidogrel(>75mg/day), or current or recent(within 10 days prior to first dose of bevacizumab) use of anticlotting drug or thrombolytic agent 4)hypertension(blood pressure systolic>150mmHg and/ or diastolic >100mmHg) with or without treatment 5)Active double malignancies 6)Radiotherapy to lung field or mediastinum 7)Evidence of tumor invading a perihilar blood vessel on imaging 8)Evidence of tumor invading segmental bronchus or subsegmental bronchus on bronchofiberscopy 9)Having a history or serious complications 10)Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration 11)Psychotic disorder 12)Uncontrolled ascites, pleural effusion or cardiac effushion 13)Double cancer less than 5 years disease free period 14)Severe drug allergy 15)ctive hepatic diseases 16)A past hypersensitive for polysorbate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Progression-free survival ( attending investigator's assessment) Response rate(RR) Overall survival(OS) Time to treatment failure QOL | — |
Countries
Japan
Contacts
Public ContactNaoyuki Nogami, Toshiyuki Kozuki
National Hospital Organization Shikoku Cancer Center Department of thoracic oncology
Outcome results
None listed