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A Phase I/II study of Pemetrexed plus Erlotinib therapy in Previously Treated Non-Small-Cell Lung Cancer.

Phase 1
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000002900
Lead Sponsor
Osaka Univ.Hospital Respiratory Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

Not provided

Exclusion Criteria

1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage 2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents 4) Patients unable to be treated with PO drugs 5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 6) Pregnancy, breast feeding and suspected pregnancy 7) Severe bone marrow suppression 8) Symptomatic brain metastasis 9) Active synchronous malignancies 10) Severe renal function disorder (creatinin clearlance less than 45mL/min) 11) Uncontrolled diabetes mellitus 12) Other clinically significant complications 13) Other conditions inadequate for this research

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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