Chemo-Naive Patients with stage IIIB and IV Non-Squamous Non-Small-Cell Lung Cancer
Conditions
Interventions
CBDCA AUC=6(day1)+ Docetaxel 60mg/m2(day1)+ Bevacizumab 15mg/kg (day1) q3weeks 4-6 cycles followed by Bevacizumab 15mg/kg (day1) q3weeks until disease progression
Sponsors
The Tokyo cooperative oncology group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) 2)Patients with stage IIIb or IV(UICC-7)or recurrent disease after surgery 3)chemo-naive patients -Adjuvant and neo-adjuvant chemotherapy are considered as one regimen of chemotherapy. -Treatment by UFT is not considered as one regimen of chemotherapy. 4)age:20-74years old 5)ECOG PS 0-1 6)Patients with measurable lesion (RECIST ver 1.1) 7)if the patient underwent therapy, there should be the following interval between the therapy and the registration. -Radiotherapy other than thoracic radiation ->2week -Surgery, ->4weeks -Thoracic drainarge->2weeks -Open biopsy, CV-port reservation, Treatment of injury->2 weeks -Aspiration biopsy, ->1 week -Postoperative Adjuvant Chemotherapy Using UFT, ->6months 8)sufficient organ function neutro>=1500/mm3 Plt >=100000/mm3 Hb >=9.0g/dl GOT/GPT <= ULNx2.5IU/L T-bil <= ULNx1.5mg/dl CCr. >= 45mL/min SpO2 >= 93% Proteinuria <=(1+) or 2g/24hr 9)Patients are expected to live over 3 months 10)Written IC
Exclusion criteria
Exclusion criteria: 1)uncontrolled infection or serious medical complications 2)massive,pleural effusion or ascites (accept controllable pleural effusion with OK-432) 3)untreated current brain metastasis 4)severe cardiac disease 5)uncontrollable hypertension 6)receiving anticoagulant drug(except Aspirin under 325mg/day) 7)current or previous histoty ofhemoptysis(2.5ml)due to NSCLC 8)history of hemoptysis(over 1week)or receive oral/i.v. hemostatic drug 9)cavity in tumor 10with great vessel invasion 11)uncontrolled hypertension 12)current or previous(within the last 1 year)history of GI perforation 13)history of myocardial infarction and cerebral infarction 14)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 15)history of drug induced interstitial pneumonia 16)The operation has been scheduled for the examination period 17)history of active double cancer within 5 years 18)history of active psychological disease 19)history of pregnancy or lactation 20)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate Overall Survival Safety Biomarker,(predictive,prognostic) | — |
Countries
Japan
Contacts
Public ContactTCOG1001 affairs office
The Tokyo cooperative oncology group Clinical Study Promotion Agency
Outcome results
None listed