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

Phase 2
Conditions
on-Small-Cell Lung Cancer
Registration Number
JPRN-UMIN000017010
Lead Sponsor
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Brief Summary

The overall response rate was 17.9%. The disease control rate was 67.9%. The median progression-free survival was 3.1 months. Adverse events were generally tolerable except grade 3 interstitial pneumonia with in 4 patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival
Secondary Outcome Measures
NameTimeMethod
Response rate Overall survival Disease control rate Rate of adverse events
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