MedTrace Logo

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

NCT02391662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Asociación de Oncología Médica del Hospital de Cruces

    lead OTHER

Principal Investigators

  • Guillermo López Vivanco, MD · Hospital de Cruces

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02391662 on ClinicalTrials.gov