Nab-paclitaxel And Gemcitabine, In Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma

Study Overview

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

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.

N/A

Pancreatic Carcinoma Metastatic

DRUG: Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4
DRUG: Gemcitabine 1000 weeks 1,2,3/4

BIBABRAX
2014-003596-27 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-08-26
First Submitted that Met QC Criteria 2015-03-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-08-28
First Posted (ACTUAL) 2015-03-18	Results First Posted N/A	Last Verified 2019-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nab-paclitaxel plus Gemcitabine Nab-paclitaxel 125 mg/m2 plus Gemcitabine 1000 days 1, 8 & 15 in a 28 days cycle	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nab-paclitaxel plus Gemcitabine

Nab-paclitaxel 125 mg/m2 plus Gemcitabine 1000 days 1, 8 & 15 in a 28 days cycle

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

Primary Outcome Measures	Measure Description	Time Frame
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.	Up to 3 months

Secondary Outcome Measures	Measure Description	Time Frame
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	Up to 6 months
Time to tumor progression	Time from patient inclusion to disease progression according RECIST criteria	Up to 8 months
Overall survival	Time from patient inclusion to death	Up to 12 months
Objective radiographic response (ORR)	Response rate will be evaluated according RECIST criteria	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	Up to 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
70 Years

Accepts Healthy Volunteers:

Histologically or cytologically-confirmed pancreatic adenocarcinoma
Stage IV disease (metastatic only)
No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
ECOG performance status of 0-1
Age >=70 years.
Evidence of either or both of the following:

RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan)
An elevated serum CA19-9 at baseline ( >= 2X ULN)
Female patients must be either surgically sterile or postmenopausal.
Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
Adequate bone marrow function:

ANC >= 1500/uL
platelet count >= 100,000/uL
hemoglobin >= 9.0 g/dL
Adequate hepatic function:

Total bilirubin <= 1.5 X ULN
AST (SGOT) <= 2.5 X ULN
ALT (SGPT) <= 2.5 X ULN
Adequate renal function as determined by either:

Serum creatinine <= 1.5 X ULN
Calculated or measured creatinine clearance >= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
Ability to understand the nature of this study protocol and give written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Any prior systemic or investigational therapy for metastatic pancreatic cancer.
Inability to comply with study and/or follow-up procedures.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
Presence of central nervous system or brain metastases.
Life expectancy < 12 weeks.
Pregnancy (positive pregnancy test) or lactation.
Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Known, existing uncontrolled coagulopathy.
Pre-existing sensory neuropathy > grade 1.
Major surgery within 4 weeks of the start of study treatment, without complete recovery.
Concurrent/pre-existing use of anticoagulant treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Apices Soluciones S.L.
Celgene

Investigators

STUDY_CHAIR: Guillermo López Vivanco, MD, Hospital de Cruces

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record