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Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer

Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer - Phase 2 study of CBDCA and weekly nab-PTX for elderly squamous cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012025
Enrollment
35
Registered
2013-10-11
Start date
2013-09-01
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

squamous cell lung cancer

Interventions

CBDCA at the dose of area under curve 5 (day1) and nab-PTX at the dose of 100mg/m2(day1.8.15)every 3 weeks ,up to 6 cycles.

Sponsors

Osaka City General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Definitively diagnosed with having squamous cell lung cancer by the specimens histologically or cytologically. 2)Clinical Stage 3B which curative radiotherapy is not indicated,4 or postoperative recurrence. 3)No prior chemotherapy. *Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted. 4)No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.) 5)At least one measurable lesion. 6)Age of 75 year or older. 7)ECOG Performance status of 0-1. 8)Sufficient major organ function as below *Neutrophil count>=1500/mm3 *Platelet count>=100000/mm3 *Hemoglobin>=9.0g/dl *total bilirubin<=1.5mg/dl *AST<=ULNX2.5 *ALT<=ULNX2.5 *Serum creatinine<=1.5mg/dl *PaO2>=60 Torr or more(or SpO2 >=95% or more) 9)Life expectancy of at least 3months 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)With active other organ cancer 2)With active infection 3)With fever equal to or more than 38C 4)With mental disorder 5)With symptomatic brain metastasis 6)Pleural and peritoneal effusion likely to require surgical intervention,or pericardial effusion 7) Systematic steroids , immunosuppressive medication or poorly controlled diabetes 8)Grade 2 or higher peripheral neuropathy 9)Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 10)poorly controlled hypertension 11)Ischemic heart disease or cardiac infarction within 6 months before enrollment 12)History of severe drug allergies 13)Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

MeasureTime frame
progression-free survival

Secondary

MeasureTime frame
overall survival,response rate,toxicities,disease control rate

Countries

Japan

Contacts

Public ContactKatsushima,Utae Katsushima,Utae

Osaka City General Hospital Department of clinical oncology

u_sota123@yahoo.co.jp06-6929-1221

Outcome results

None listed

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