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Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients

Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients - Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014019
Enrollment
20
Registered
2014-05-21
Start date
2008-10-20
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

Lung cancer

Interventions

AMR 30mg/m2 day1-3, PTX 70mg/m2 day4,11 repeat every 3 weeks for minimum 2 cycles.

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 histologically or cytologically confirmed NSCLC 2 recurrent patients treated with 1 or 2 regimens 3 measurable disease 4 life expectancy of at least 3 months. 5 >70 age years >=20 6 performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale 7 adequate organ function adequate bone marrow (leukocyte count 12,000>= >=3,000/mm3, neutrophil count > =1,500/mm3, hemoglobin concentration > =9.5g/dL, platelet count >= 100,000 /mL), kidney (creatinine <= 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =100, total bilirubin <= 2.0 mg/dL)

Exclusion criteria

Exclusion criteria: 1 active concomitant malignancies,infections 2 symptomatic brain metastases 3 past history of severe allergic reactions to drugs 4 interstitial pneumonia identified by chest X-ray 5 bone metastasis or hypercalcemia required immediate treatment 6 other serious complications, such as uncontrolled angina pectoris,myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites. 7 allergie for PTX

Design outcomes

Primary

MeasureTime frame
RR

Secondary

MeasureTime frame
safety, PFS, OS

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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