Weekly nab-PTX in Combination with Gemcitabine in Patients with Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy

UMIN ID: UMIN000017010

Registered date:01/04/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-Small-Cell Lung Cancer
• Date of first enrollment: 2015/04/16
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): nab-paclitaxel(100mg/ m2 day1,8) Gemciabine (1000mg/ m2 day1, 8) The treatment is repeated every three weeks until disease progression or severe toxicity.

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Response rate Overall survival Disease control rate Rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)history of drug induced interstitial pneumonia 3)history of severe drug allergy 4)patients previously treated with paclitaxel, gembcitabine, nab-paclitaxel. 5)history of active infection or other serious disease condition 6)history of poorly controlled pleural effusion,pericardial effusion and ascites 7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.) 8)uncontrollable diabetes mellitus 9)curative radiotherapy pretreated to the chest. 10)current neuropathy >Grade2 11)history of active double cancer 12)history of active psychological disease 13)history of pregnancy or lactation 14)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Related Information

• Primary Sponsor: Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
• Source(s) of Monetary Support: Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine