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

Sponsor
Asociación de Oncología Médica del Hospital de Cruces (Other)
Overall Status
Completed
CT.gov ID
NCT02391662
Collaborator
Apices Soluciones S.L. (Industry), Celgene (Industry)
80
Enrollment
21
Locations
1
Arm
44.3
Actual Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4
  • Drug: Gemcitabine 1000 weeks 1,2,3/4
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Actual Study Start Date :
Jun 23, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of treatment through 3-months deterioration free rate [Up to 3 months]

      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.

    Secondary Outcome Measures

    1. Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria [Up to 6 months]

      Number of events per patient according to NCI-CTC-AE criteria

    2. Time to tumor progression [Up to 8 months]

      Time from patient inclusion to disease progression according RECIST criteria

    3. Overall survival [Up to 12 months]

      Time from patient inclusion to death

    4. Objective radiographic response (ORR) [Up to 6 months]

      Response rate will be evaluated according RECIST criteria

    5. CA 19.9 biomarker response [Up to 6 months]

      CA 19.9 biomarker response will be considered a decrease of at least 50% compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital General de Granollers Granollers Barcelona Spain 08402
    2 Centre Hospitalari de Manresa Manresa Barcelona Spain 08240
    3 Hospital Universitario de Cruces Barakaldo Gipuzkoa Spain 48903
    4 Hospital Clinico Universitario Virgen de La Arrixaca El Palmar Murcia Spain 30120
    5 Hospital Xeral de Vigo Vigo Pontevedra Spain 36204
    6 Complejo Hospitalario Universitario de Canarias San Cristóbal de La Laguna Tenerife Spain 38320
    7 Hospital General Universitario de Alicante Alicante Spain 03010
    8 Hospital Infanta Cristina Badajoz Spain 06080
    9 Hospital Universitario Vall D'Hebron Barcelona Spain 08035
    10 Hospital Universitario de Burgos Burgos Spain 09006
    11 Ico Girona Girona Spain 17007
    12 Complejo Hospitalario de Jaén Jaén Spain 23007
    13 C. Hospitalario Universitario Insularmaterno-Infantil Las Palmas de Gran Canaria Spain 35016
    14 Hospital Universitario Lucus Augusti Lugo Spain 27003
    15 Hospital Universitario de La Princesa Madrid Spain 28006
    16 Hospital Universitario La Paz Madrid Spain 28046
    17 Hospital Universitario Hm Sanchinarro Madrid Spain 28050
    18 Hospital Quirón Madrid Madrid Spain 28223
    19 Complexo Hospitalario Universitario de Ourense Ourense Spain 32005
    20 Complejo Hospitalario Regional Virgen Macarena Sevilla Spain 41009
    21 Hospital Virgen Del Rocio Sevilla Spain 41013

    Sponsors and Collaborators

    • Asociación de Oncología Médica del Hospital de Cruces
    • Apices Soluciones S.L.
    • Celgene

    Investigators

    • Study Chair: Guillermo López Vivanco, MD, Hospital de Cruces

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asociación de Oncología Médica del Hospital de Cruces
    ClinicalTrials.gov Identifier:
    NCT02391662
    Other Study ID Numbers:
    • BIBABRAX
    • 2014-003596-27
    First Posted:
    Mar 18, 2015
    Last Update Posted:
    Aug 28, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Asociación de Oncología Médica del Hospital de Cruces
    Metastatic Pancreatic Adenocarcinoma
    Elderly
    Nab-paclitaxel
    Gemcitabine
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms
    Gemcitabine
    Paclitaxel
    Albumin-Bound Paclitaxel

    Study Results

    No Results Posted as of Aug 28, 2019