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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Nab-paclitaxel 125 mg/m2 days 1,8 \& 15 in a 28 days cycle
Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle
Hospital General de Granollers
Granollers, Barcelona, Spain
Centre Hospitalari de Manresa
Manresa, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Gipuzkoa, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
...and 11 more locations
Efficacy of treatment through 3-months deterioration free rate
The general deterioration of the patient is assessed with the EORTC-QLQ-C30 scale. t will be considered definitive deterioration a decrease of at least 10 points from baseline. We will evaluate the rate of patients free of definitive deterioration at 3 months.
Time frame: Up to 3 months
Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria
Number of events per patient according to NCI-CTC-AE criteria
Time frame: Up to 6 months
Time to tumor progression
Time from patient inclusion to disease progression according RECIST criteria
Time frame: Up to 8 months
Overall survival
Time from patient inclusion to death
Time frame: Up to 12 months
Objective radiographic response (ORR)
Response rate will be evaluated according RECIST criteria
Time frame: Up to 6 months
CA 19.9 biomarker response
CA 19.9 biomarker response will be considered a decrease of at least 50% compared to baseline
Time frame: Up to 6 months
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