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A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer

A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer - A phase II study of Docetaxel with Bevacizumab elderly patients with NSCLC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005619
Enrollment
35
Registered
2011-05-19
Start date
2010-12-01
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

Non-squamous non-small cell lung cancer

Interventions

Six cycles of Docetaxel + Bevacizumab followed by maintenance Bevacizumab until disease progression

Sponsors

Osaka Lung Cancer Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients 2) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease 3) Patients aged 70- years 4) ECOG performance status 0-1 5) Adequate organ function 6) Excepted to live over 3 months after administration day 7) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Severe renal function disorder 5) SVC syndrome 6) Brain metastases with neurological symptoms 7) Active double cancer 8) Uncontrollable diabetes mellitus and hypertenson 9) Liver cirrhosis by image findings or laboratory examinations 10) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 11) Pregnancy, breast feeding and suspected pregnancy 12) History of grave drug allergic reaction 13) Acute inflammatory disease 14) An agreement is not obtained for support therapy such as transfusion etc 15) Having the bleeding tendency which is clinically apparent 16) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

MeasureTime frame
RR: response rate—

Secondary

MeasureTime frame
PFS: progression free survival OS: overall survival DCR: disease control rate AE: Adverse events—

Countries

Japan

Contacts

Public ContactNaruo Yoshimura

Graduate School of Medicine, Osaka City University Department of Respiratory Medicine

y-naruo@sc4.so-net.ne.jp06-6645-3793

Outcome results

None listed

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