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Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial

Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial - Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024505
Enrollment
60
Registered
2016-10-20
Start date
2016-11-15
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

Metastatic pancreatic cancer

Interventions

To receive a 30-minite intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine at a dose of 1000 mg per square meter for standard group, on

Sponsors

Kindai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed adenocarcinoma of the pancreas 2)Metastatic pancreatic cancer 3)Case that is measurable. Imaging examination is finished within 4 weeks. 4)Case that chemotherapy or radiation had not been performed. 5)More than 65-years-old 6)Performance Status 0 or 1 7)Case without major organ disorders 8)Case without abnormality on ECG within 4 weeks 9)Obtain informed concent

Exclusion criteria

Exclusion criteria: 1)Pulmonary fibrosis/pneumonia interstitialis 2)Serous diarrhea 3)Active infection 4)Serious complication 5)modelate or severe pleural effusion/ascites 6)Brain metastasis with sympsons 7)Active multiple primary cancer 8)Use of warfarin potassium 9)During pregnancy 10)Serious mental disorders 11)The other inappropriate case

Design outcomes

Primary

MeasureTime frame
Response rate

Countries

Japan

Contacts

Public ContactKen Kamata

Kindai University Gastroenterology and Hepatology

ky11@leto.eonet.ne.jp072-366-0221

Outcome results

None listed

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