Non-small cell lung cancer
Conditions
Interventions
DOC(60 mg/m2, day 1)+ RAM(10 mg/kg, day 1)&
PEG-G-CSF(3.6 mg, day 2-4) every 3 weeks until progression or both DOC and RAM termination
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged <= 75 2.Written informed consent 3.Histologically or cytologically confirmed NSCLC 4.Stage IIIb without indication of definitive chemoradiotherapy, stage IV, or recurrence after surgery 5.Presence of measurable lesions 6.No symptomatic brain metastases and/or spiral metastases with requirement of surgery 7.No symptomatic superior vena cava syndrome 8.No uncontrolled cardiac, pleural, or abdominal effusion 9.No radiographic findings of ramucirumab restriction I. No cancer invasion to major vessels and/or major vessel stenosis II. No cavitation regardless of histology III. No tumor exposure to main bronchus 10.ECOG PS 0/1 11.Normal labo data WBC >= 3,000/mm3 Neut >= 1,500/mm3 Hb >= 9.0 g/dL Plt >= 10 x 10^4 / mm3 T-bil <= 1.5 mg/dL AST/ALT <= 100 IU/L (<= 200 IU/L by liver metastases) CRE <= 1.5 mg/dL PT-INR <= 1.5 SpO2 <= 92% Protein uria <= 1+ 12.No active hepatitis B infection 13.No history of receiving cytotoxic chemotherapies and ramucirumab 14.Recurrent cases after surgery, 1 prior adjuvant chemotherapy is permitted 15.No history of recent surgery 16.Interval >= 7 days after palliative radiation therapies 17.No prior chest radiotherapy for primary disease 18.No history of chest radiotherapy and chemotherapy against cancers other than primary disease
Exclusion criteria
Exclusion criteria: 1) Active multiple cancer 2) Active infection 3) Interstitial pneumonia/pulmonary fibrosis 4) Uncontrolled diabetes 5) Uncontrolled hypertension 6) Clinically significant heart failure or uncontrolled arythmia 7) Ileus, inflammatory bowel disease, or chronic diarrhea 8) Uncontrolled thromboembolism 9) HIV associated disease 10) Severe psychological disease 11) Severe liver dysfunction such as cirrhosis 12) Prescription of steroids and/or immunosuppressant 13) Anticoaglation with warfarin or heparin 14) Prescription of long-term NSAIDS or antiplatelets 15) Fever >= 38.0 degrees C 16) Recent history of hemoptysis 17) Recent history of cardio-brain vascular disease 18) Incurable wound, ulcer, or bone fracture 19) Recent history of bleeding, vasculitis, or gastrointestinal hemorrhage 20) Recent history of gastrointestinal perforation/fistula 21) History of hypersensitivity by agents containing polysorbate 80 22) Plan of major surgery during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, overall survival, and safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed