recurrent or advanced non-squamous non-small-cell and lung cancer.
Conditions
Interventions
Four cycles of Pemetrexed + Carboplatin followed by maintenance Pemetrexed until Clinical disease progression
Sponsors
Dept. of Respiratory Medicine, Osaka University Hospital
OULCSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent) 2) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy 3) Patients aged 20 years or older 4) Karnofsky performance status 70-100 5) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST 6) Adequate organ function 7) Excepted to live over 3 months after administration day 8) Written informed consent from the patients
Exclusion criteria
Exclusion criteria: Patients with at least one of the following conditions are ineligible 1)Have central nervous system metastases 2) Radiological evidence of tumor invading or abutting major blood vessels and evidence of brain metastases, even if previously treated. But eligible for disappeared or controlled brain metastases 3)history of active double cancer within 5 years 4)History of hemoptysis with 2.5mL or more. a) continue hemosputum for more than one week b) have had or require continuous oral administration of hemostat c) have had or require injectable administration of hemostat 5)Have possibly complication related to bleeding episode 6)Great vessel involvement 7)Have received radiation therapy to lesions of lung 8)Currently have or have a history of a cardiac effusion which requires treatment 9)Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment 10)Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 11)Operation has been scheduled for the treatment period 12)Receiving anticoagulant drug(including Aspirin over 325mg/day). 13)Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year. 14)Uncontrollable Hypertension or Gastrointestinal ulceration 15)Severe cardiac disease 16)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 17)Peripheral neuropathy > Grade2 18)Hypersensitivity of Protocol agents or Taxans or alcohol and the medicine made of the polio castor oil content. 19)Cases with past history of administration of Protocol agents 20) Pregnancy, breast feeding and suspected pregnancy 21) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety Objective response rate Overall Survival | — |
Countries
Japan
Contacts
Public ContactTakashi Kijima
Osaka University Hospital Dept. of Respiratory Medicine
Outcome results
None listed