Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.

Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy. - Phase II pilot study of nab-paclitaxel in patients with metastatic or unresectable urothelial cancer previously treated with cisplatin-based chemotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015260

Enrollment

Registered

2014-09-26

Start date

2014-09-11

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

urothelial cancer

Interventions

Nab-paclitaxel (260mg/m2) will be administered every 3 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) ECOG performance status 0~2 2) Patients with cytologically and/or histologically confirmed urothelial carcinoma 3) Patients with metastatic or unresectable urothelial cancer previously treated cisplatin-based chemotherapy 4) At least one or more measurable lesion by RECIST ver1.1 5) Laboratory requirements a) WBC >=3000/mm3 b) neutrophil >=1500/mm3 c) Hemoglobin >=9.0g d) Platelet >=100000/mm3 e) Total bilirubin <=1.5 times of upper limit of normal f) AST and ALT <=2.5 times of upper limit of normal g) serum Creatinine <=1.5mg/dL h) Normal ECG 6) Life expectancy more than three months 7) Signed informed consent is obtained prior to the entry to this clinical study.

Exclusion criteria

Exclusion criteria: Patients 1) have a treatment history of paclitaxel treatment 2) have an allergy to albumin 3) have a heavy infection 4) have severe complications: interstitial pulmonary fibrosis, gastrointestinal hemorrhage, ileus, uncontrollable diabetes mellitus, cardiovascular disease, etc. 5) have an uncontrollable pleural, ascites or pericardial effusion. 6) have an active cancer except urothelial cancer: cancer free duration < 5 years. 7) have a brain metastasis with symptoms requiring steroids or anti-seisure medications 8) have a history of salvage radiation to primary organ or lymph node metastasis within two weeks. 9) do not meet the inclusion criteria due to mental disorders or neurological symptoms 10) have no intention to birth control 11) disqualified by a doctor in charge

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Safety, Progression free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactAkihiro Yano

Saitama Medical Center, Saitama Medical University Urology

yanoaki@saitama-med.ac.jp049-228-3673

Outcome results

None listed

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