JPRN-UMIN000005328
Recruiting
Phase 2
A Phase II study of Paclitaxel plus Carboplatin plus Bevacizumab that introduces concept of Clinical PD in recurrent or advanced non-squamous non-small cell lung cancer. - A Phase II study of Paclitaxel plus Carboplatin plus Bevacizumab that introduces concept of Clinical PD in recurrent or advanced non-squamous non-small cell lung cancer.
Dept. of Respiratory Medicine, Osaka University Hospital0 sites45 target enrollmentApril 1, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- recurrent or advanced non-squamous non-small-cell and lung cancer.
- Sponsor
- Dept. of Respiratory Medicine, Osaka University Hospital
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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