NCT02391662

Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma

A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Asociación de Oncología Médica del Hospital de Cruces · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Since there is no specific recommendations for treatment of elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of choice for these patients. Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and targeted agents to gemcitabine has almost invariably provided no significant survival improvement. Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in overall survival, but due to in this clinical trial was included patients between 27 and 88 years, it is considered necessary to conduct a specific study for patients over 70 years. The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel associated with gemcitabine can be extended to elderly patients with pancreatic cancer.

Conditions

• Pancreatic Carcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4	Nab-paclitaxel 125 mg/m2 days 1,8 \& 15 in a 28 days cycle
DRUG	Gemcitabine 1000 weeks 1,2,3/4	Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Timeline

• Start date: 2015-06-23
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2015-03-18
• Last updated: 2019-08-28

Locations

21 sites across 1 country: Spain