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Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018322
Enrollment
35
Registered
2015-07-15
Start date
2012-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia

Interventions

carboplatin AUC = 5, day1 paclitaxel 70mg/m2, day1 ,8 ,15 bevacizumab 15mg/kg, day1 every 4 weeks, 4-6 cycle

Sponsors

IP lung cancer study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) non-squamous, non-small cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) expected treatment date to be 4 weeks over surgury, 2 weeks over drainage of pleural effusion, 2 weeks over biopsy requiring incision, 1 week over bronchoscopic procedure or implantation of central venous port 6) ECOG performance status 0 or 1 7) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, urine protein<= 1+ 8) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 9) Life expectancy > 3 months 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Secondary interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) In need of home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) brain metastasis. 10) Uncontrollable effusion. 11) history of hemosputum 12) tumor invasion into thoracic large vessels or tumor with cavity 13)active gastrointestinal ulcer 14)bleeding tendency 15)operation wound not cured 16)thrombosis in need with treatment 17) Active combined malignancy 18) Any ineligible case judged by physician.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
OS: overall survival PFS: progression free survival TTF: time to treatment failure toxicity

Countries

Japan

Contacts

Public ContactKojiro Otsuka

Kobe City Medical Center General Hospital Department of Respiratory Medicine

kotsuka@kcho.jp078-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026