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A phase II study of nab-paclitaxel for pretreated non-small cell lung cancer

A phase II study of nab-paclitaxel for pretreated non-small cell lung cancer - A phase II study of nab-paclitaxel for pretreated non-small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012972
Enrollment
30
Registered
2014-01-27
Start date
2013-11-19
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-small cell lung cancer

Interventions

nab-paclitaxel is administered at a dose of 100mg/m2 intravenously on day1,8,15. A treatment cycle is repeated every 21-28 days.

Sponsors

Kanagawa Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed non-small cell lung cancer 2)unresectable disease 3)The presence of measureable lesions 4)Age of 20 years or older 5)Life expectancy more than 12weeks 6)ECOG Perfomance status 0-2 7) Previous 1-2 regimen chemotherapy consisting of platinum 8)oral UFT for adjuvant chemotherapy do not count as 1 regimen 9)EGFR-TKI or ALK inhibiter do not count as 1 regimen 10)Interval of more than 28 days from the last chemotherapy or radiotherapy 11)preserved organ's function WBC>=3,000/mm3 Hemoglobin>= 9.0g/dl Platelet count>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT <100 IU/l Serum creatinine <=1.5mg/dl 12)Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1)patients previously treated with paclitaxel derivative drugs 2)Anamnesis of hypersensitivity to albumin 3)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case) 4)evident pericardial effusion 5)serious complications below uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure uncontrollable diabetes uncontrollable hypertension severe infection 6)pulmonary fibrosis or interstitial pneumonitis evident 7)HB and HC virus carrier 8)now pregnant or lactation 9)difficult to perform or continue of this study

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival, Progression free survival, frequency of adverse events

Countries

Japan

Contacts

Public ContactShuji Murakami

Kanagawa Cancer Center Department of Thoracic Oncology

murakamis@kcch.jp045-520-2222

Outcome results

None listed

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