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

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 Overview

• Status: Completed
• Conditions: Pancreatic Carcinoma Metastatic
• Intervention / Treatment: Drug: Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4; Drug: Gemcitabine 1000 weeks 1,2,3/4

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Badajoz, Spain, 06080
    • Hospital Infanta Cristina
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Girona, Spain, 17007
    • ICO Girona
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • Las Palmas de Gran Canaria, Spain, 35016
    • C. Hospitalario Universitario Insularmaterno-Infantil
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain, 28223
    • Hospital Quiron Madrid
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocio
  • Sevilla, Spain, 41009
    • Complejo Hospitalario Regional Virgen Macarena
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Hospital General de Granollers
    • Manresa, Barcelona, Spain, 08240
      • Centre Hospitalari de Manresa
  • Gipuzkoa
    • Barakaldo, Gipuzkoa, Spain, 48903
      • Hospital Universitario de Cruces
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de la Arrixaca
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral de Vigo
  • Tenerife
    • San Cristóbal de La Laguna, Tenerife, Spain, 38320
      • Complejo hospitalario Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: Nab-paclitaxel; Drug: Gemcitabine 1000 weeks 1,2,3/4; Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle; Other Names: Gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Asociación de Oncología Médica del Hospital de Cruces
• Collaborators: Celgene; Apices Soluciones S.L.
• Investigators: Study Chair: Guillermo López Vivanco, MD, Hospital de Cruces

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Gemcitabine; Elderly; Nab-paclitaxel; Metastatic Pancreatic Adenocarcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: BIBABRAX; 2014-003596-27 (EudraCT Number)