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Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.

Phase 2
Conditions
Recurrent squamous cell lung cancer
Registration Number
JPRN-UMIN000006270
Lead Sponsor
Kansai Medical University Hirakata Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1)Uncontrolled infection or Serious medical complications 2)Massive pleural effusion or ascites after drainage and controrable pleural effusion for 2 weeks accept controrable pleural effusion with OK-432 3)current or previous treated brain metastasis 4)severe cardiac disease 5)uncontrolled diabetes mellitus 6)receiving anticoagulant drug(except Aspirin under 325mg/day) 7)uncontrolled hypertension 8)current or previous (within the last 1 year) history of GI perforation 9)interstitial pneumonia or lung fibrosis evident on CT 10)history of drug induced interstitial pneumonia 11)patient who has been scheduling operation for examination period 12)treatment history of Amurubicin 13)severe drug allergy 14)active concomitant malignancy 15)severe psychological disease 16)pregnant or lactating women or those who declined contraception 17)those judged to be not suitable by the attending physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate
Secondary Outcome Measures
NameTimeMethod
Overall survival Progression Free Survival Adverse events
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