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Trial record 77 of 851 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel (QOLINPAC)

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ClinicalTrials.gov Identifier: NCT02106884
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

This is a quality of life study done in the context of a randomized trial in pancreatic cancer. Patients with locally advanced or metastatic pancreatic adenocarcinoma receive either the combination of nab-paclitaxel gemcitabine or the existing standard gemcitabine alone treatment.The combination regimen of nab-paclitaxel and gemcitabine administered in patients with locally advanced or metastatic pancreatic cancer in a first line setting showed improved efficacy with acceptable toxicity. The current study design allows patients in standard treatment to receive the combination treatment at tumour progression.

The proposed study will explore the impact of treatment on the quality of life and compare the times to definitive deterioration of the quality of life scores using the validated EORTC QLQ-C30. Efficacy and safety secondary endpoints are to be reported in a descriptive manner.

Molecular studies will be performed on blood and tissue samples.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Abraxane (nab-paclitaxel) Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Crossover Trial to Assess the Effects and Quality of Life in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine in Combination With Nab-paclitaxel: QOLINPAC
Actual Study Start Date : April 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Arm A
Abraxane (nab-paclitaxel) - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
Drug: Abraxane (nab-paclitaxel)
Other Name: Abraxane, nab-paclitaxel, EU/1/07/428/001, L01CD01

Drug: Gemcitabine
Other Name: Gemzar

Active Comparator: Arm B
Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
Drug: Gemcitabine
Other Name: Gemzar




Primary Outcome Measures :
  1. Deterioration free rate of quality of life (QOL) scores at three months [ Time Frame: upto 12 months ]
    QOL questionnaires will be applied to patients every 4 weeks for a maximum of 12 months. The primary endpoint will be analysed at the end of the study.


Secondary Outcome Measures :
  1. Safety and tolerability profile (NCI-CTCAE v. 4.0) [ Time Frame: Weekly upto 12 months ]
    Descriptive safety, incidence of treatment-emergent toxicities in both arms and incidence of dose modifications, interruptions and discontinuations.

  2. Overall response and duration of response [ Time Frame: q8 weeks upto 12 months ]
    Response and disease control rates - response evaluation will be performed every 8 weeks according to RECIST criteria (CT/ MRI scan)

  3. Progression free survival [ Time Frame: q8 weeks for 12 months, routine for upto 36 months ]
    From date of randomization until the date of progression assessed up to 36 months

  4. Overall survival [ Time Frame: From date of randomization until the date of death from any cause assessed up to 36 months ]
    From date of randomization until the date of death from any cause assessed up to 36 months

  5. Changes in serum CA 19-9 and CEA and composite index CA19-9xCEA [ Time Frame: Every 8 weeks upto 12 months ]
    Evolution of the levels of carbohydrate antigen 19 9 (CA19 9) on treatment (q 8 weeks) and composite index.

  6. Exploratory biomarker and hypoxia studies on blood products and tumour tissues with possible correlations with efficacy outcomes [ Time Frame: Baseline for tissue; 3 timepoints for blood collection(baseline, Week 9, Progression - maximum 12 months) ]

    Biomarkers that can be related with benefit to nab-paclitaxel:

    • Potential SNPs
    • Circulating DNA
    • Circulating micro-RNA
    • Selected cytokines (ELISA)
    • hENT1, SPARC, dCK and S100A2 expression (immunohistochemistry/qPCR)

    Hypoxia studies




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/local regulations.
  • Patient is at least 18 years of age .
  • Unresectable locally advanced or metastatic pancreatic cancer.
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell neoplasms are excluded.
  • Evaluable or measurable disease, not in a previously irradiated area.
  • Life expectancy of at least 12 weeks.
  • WHO ECOG performance status ≤ 2
  • Adequate organ function.
  • Adequate bone marrow, hepatic and renal function:

Acceptable coagulation (prothrombin time and partial thromboplastin time within +/- 15% of normal limits).

  • No clinically significant abnormalities in urinalysis.
  • Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.

Exclusion criteria:

  • Prior chemotherapy, radiotherapy, surgery or other investigational therapy for the treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is allowed provided at least 6 months have elapsed since completion of the last dose.
  • Major surgery within 4 weeks of the start of the study.
  • Irradiation within 3 weeks prior to study entry.
  • Brain metastasis (known or suspected).
  • Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk including coronary stenting or myocardial infarction in the last year and psychiatric disorders.
  • Historical or active infection with HIV, hepatitis B or C.
  • History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
  • History of interstitial lung disease.
  • History of peripheral artery disease.
  • Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
  • Known allergy or any other adverse reaction to any of the drugs or to any related compound.
  • Use of Coumadin.
  • Organ allografts requiring immunosuppressive therapy.
  • Pregnancy or breast-feeding.
  • Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106884


Locations
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Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium, 9300
AZ Klina
Brasschaat, Belgium, 2930
AZ St Lucas
Brugge, Belgium, 8310
ULB Hôpital Erasme
Brussels, Belgium, 1070
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
CHU de Charleroi
Charleroi, Belgium, 6110
UZ Antwerpen
Edegem, Belgium, 2650
AZ Maria Middelares
Gent, Belgium, 9000
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
CHC St Joseph
Liege, Belgium, 4000
CHR Citadelle
Liege, Belgium, 4000
CHU Sart-Tilman
Liege, Belgium, 4000
Heilig Hartziekenhuis Lier
Lier, Belgium, 2500
AZ Sint Maarten
Mechelen, Belgium, 2800
Clinique St Elisabeth
Namur, Belgium, 5000
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium, 2300
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Celgene Corporation
Investigators
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Principal Investigator: Eric Van Cutsem, MD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02106884     History of Changes
Other Study ID Numbers: s56122
2013-004101-75 ( EudraCT Number )
AX-CL-PANC-PI-003568 ( Other Grant/Funding Number: Celgene )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Pancreatic cancer
Locally advanced
Metastatic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs