A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer - A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011696

Enrollment

Registered

2013-09-11

Start date

2013-08-01

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

Non-small cell carcinoma

Interventions

Abraxane (100mg/m2) is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed advanced non-small-cell lung cancer 2) Patients with NSCLC (advanced stage or recurrent disease) previously treated with chemotherapy 3) Performamne status of 0 or 2 4) 20 years of age or older 5) The presence of mesurable lesions by RECIST 6) Cases survival of 8 weekss or more is expected 7) Written informed consents 8) Adequate organ funcion White blood cell count >= 3,000 /mm3 Neutrophil count >= 1,500 /mm3 Hemoglobin >= 9.0 g/dL Platelet count >= 100,000 /mm3 AST and ALT x 2.5 of upper limit of normal (ULN) or less Total bilirubin <or= 1.5 mg/dL Serum creatinine x 1.5 of upper limit of normal (ULN) or less Pao2 >= 60 torr or SPo2 >= 95% 9) Interval from previous chest radiotherapy: more than 12 weeks after the last irradiation to lung (paliative radiation to bone is excluded) 10) Interval from previous treated with intrapleural therapy for malignant pleural effusion: more than 1 week 11) Interval from previous chemotherapy: more than 1 week

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray 2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 3) Severe infection 4) History of active double cancer within 5 years prior to the study 5) Sympyomatic brain metastasis 6) Massive pleural effusion requiring treatment 7) Patients who are pregnant,considering pregnancy oractaing 8) Other conditions not suitable forthis study

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression-free survival, safety	—

Countries

Japan

Contacts

Public ContactHisashi Tanaka

Hirosaki University Graduate School of Medicine Department of Cardiology, Respiratory Medicine and Nephrology

xyghx335@gmail.com0172-39-5057

Outcome results

None listed

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